Gedeon Richter 
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91 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Vraylar (cariprazine) / Mitsubishi Tanabe, Recordati, Gedeon Richter, AbbVie
2020-005726-29: An open label signal detection study to evaluate the effects of cariprazine on cognitive functioning in patients with schizophrenia in need of adjustment of oral antipsychotic treatment

Not yet recruiting
4
20
Europe
Capsule, hard, Reagila
Medical University Innsbruck, Gedeon Richter Plc.
Schizophrenia, Schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2021-001268-58: Investigation of effects of cariprazine in patients with mitochondrial schizophrenia A cariprazine hatásának vizsgálata mitochondriális dysfunkcióval asszociált schizophreniában

Not yet recruiting
4
10
Europe
Reagila, Capsule, Reagila
Semmelweis University, STIA-POC-2020, Semmelweis University, STIA-POC-2020, Gedeon Richter
Mitochondrial disease associated schizophrenia Mitochondrialis betegséghez társuló schizophrenia, schizophrenia associating with mitochondrial disease schizophrenia, amely mitochondrialis betegséghez társul, Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
 
 
2021-006706-69: Lithium versus cariprazine in the treatment of bipolar depression

Not yet recruiting
4
122
Europe
Cariprazine, lithium citrate, Capsule, hard, Tablet, Reagila, Litarex
Psychiatry – Aalborg University Hospital, Unit for Psychiatric Research, Danske Regioner, Region Nordjylland
Bipolar disorder, current depressive episode. -Bipolar affektiv lidelse, aktuel depressiv episode, Patients with a diagnoses of bipolar disorder who have a depressive episode, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT04843423: Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder

Recruiting
4
15
Canada
Cariprazine
Dr. Martin A. Katzman
Attention Deficit Hyperactivity Disorder
12/22
04/23
NCT05384483: Cariprazine Versus Placebo for Social Anxiety Disorder

Completed
4
40
US
Cariprazine, Vraylar®, Placebo
The Medical Research Network, AbbVie
Social Anxiety Disorder
04/24
04/24
DUAG9, NCT05913947 / 2021-006706-69: Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression

Recruiting
4
122
Europe
Lithium, Litarex, ATC; N05AN01, Cariprazine, Reagila, ATC: N05AX15
Aalborg University Hospital, Mental Health Center, Glostrup, Mental Health Center North Zealand, Mental Health Department Odense, University Clinic, Psychiatric Center Copenhagen, Rigshospitalet
Depression, Bipolar
09/24
09/24
SMART-BD, NCT06433635: Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Recruiting
4
2726
Canada, US
Cariprazine, Vraylar, Aripiprazole/Escitalopram combination, Abilify/ Lexapro, Quetiapine, Seroquel, Lurasidone, Latuda
Massachusetts General Hospital, Patient-Centered Outcomes Research Institute
Bipolar I Disorder, Depression
02/30
02/30
NCT05060549: Dopamine D3 Receptor Occupancy in Bipolar Depression

Not yet recruiting
4
8
US
Cariprazine, Vraylar
New York State Psychiatric Institute
Bipolar Depression
12/26
12/26
NCT05741502: An Exploratory Analysis of Immune and Inflammatory Response Associated with Clozapine

Recruiting
4
60
US
Clozapine, Antipsychotics,Other (non-Clozapine), Including Olanzapine, Risperidone, Paliperidone, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, and all Typical antipsychotics
Ohio State University
Treatment-resistant Schizophrenia
03/26
06/26
NCT05933538: Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

Not yet recruiting
4
110
NA
Cariprazine, Treatment as usual
Sultan Qaboos University
Depressive Disorder, Major
08/30
12/30
2018-004590-27: Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia

Ongoing
3
300
Europe
cariprazine, RGH-188, Capsule, hard, Reagila
Gedeon Richter Plc, Gedeon Richter Plc
Adolescent patient (13-<18 years of age) with Schizophrenia, Adolescent patient (13-<18 years of age) with Schizophrenia, Diseases [C] - Nervous System Diseases [C10]
 
 
2018-004006-26: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 years of age) with Schizophrenia

Ongoing
3
330
Europe
cariprazine, RGH-188, Capsule, hard
Allergan Ltd, Allergan Ltd.
Adolescent Patients (13 to 17 years of age) with Schizophrenia, Adolescent Patients (13 to 17 years of age) with Schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2018-003164-31: The purpose of this study is to look into the safety and efficacy ofcariprazine as an add-on medication in the treatment of major depressivedisorder.

Not yet recruiting
3
750
RoW, Europe
Cariprazine, Capsule
Allergan Ltd., Allergan Sales LLC
Major Depressive Disorder, Clinical Depression, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT04519099 / 2017-000818-34: Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

Recruiting
3
345
Europe, US, RoW
Cariprazine, Placebo
Allergan, Allergan Ltd
Schizophrenia
04/22
04/22
NCT05168007: Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

Enrolling by invitation
3
342
RoW
WID-RGC20(Cariprazine) 3mg/day, WID-RGC20(Cariprazine) 6mg/day, Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
Whanin Pharmaceutical Company
Schizophrenia
07/23
07/23
NCT05439616: Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD

Completed
3
161
US
Cariprazine, VRAYLAR, AGN-241780, Placebo
AbbVie
Autism Spectrum Disorder
10/24
10/24
NCT04777357: A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

Recruiting
3
380
US, RoW
Cariprazine, Vraylar, Placebo
AbbVie
Depression, Bipolar I Disorder
03/27
03/27
NCT03817502 / 2018-004006-26: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Recruiting
3
330
Europe, US, RoW
Cariprazine, Placebo
Gedeon Richter Plc., Allergan Ltd.
Schizophrenia
04/25
04/25
NCT05368558: Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia

Terminated
3
34
Japan, RoW
Cariprazine, VRAYLAR, Placebo
AbbVie
Schizophrenia
09/24
09/24
NCT04578756: Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

Active, not recruiting
3
310
US
Cariprazine Flexible Dose
AbbVie
Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD)
09/25
09/25
CARPZ-01, NCT04771299: Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients

Terminated
3
1
Canada
Cariprazine, VRAYLAR®, Placebo
Lakshmi N Yatham
Bipolar I Disorder, Cognitive Impairment
09/24
09/24
NCT05063201: Cariprazine for Comorbid Cocaine and Opioid Use Disorder

Recruiting
2
48
US
Cariprazine 1.5 MG, Placebo
Kyle Kampman, National Institute on Drug Abuse (NIDA)
Opioid-use Disorder, Cocaine Use Disorder
12/25
12/25
CReW BP-I, NCT06256367: Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder

Recruiting
N/A
170
Canada, US
AbbVie
Bipolar I Disorder
07/25
07/25
Orgovyx (relugolix) / Takeda, Sumitomo Pharma, Pfizer
SPIRIT EXTENSION, NCT03654274 / 2017-004066-10: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

Completed
3
802
Europe, Canada, US, RoW
Relugolix, TAK-385, MVT-601, Estradiol/norethindrone acetate, E2/NETA, low-dose hormonal add-back
Myovant Sciences GmbH
Endometriosis
12/21
01/23
SERENE, NCT04756037: Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

Active, not recruiting
3
1020
US
Relugolix Combination Therapy, Myfembree
Sumitomo Pharma Switzerland GmbH
Contraception
02/25
02/26
NCT06439524: The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial

Recruiting
3
110
US
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, Relugolix Combination Therapy (Rel-CT), Myfembree
Main Line Health, Pfizer, Sumitomo Pharma Switzerland GmbH
Endometriosis
02/26
08/26
NCT06671548: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Not yet recruiting
3
120
RoW
Relugolix, megestrol acetate, medroxyprogesterone acetate, Relugolix placebo, megestrol acetate placebo, medroxyprogesterone acetate placebo
Qilu Pharmaceutical Co., Ltd.
Heavy Menstrual Bleeding, Uterine Fibroids
12/26
02/27
REVELUTION-2, NCT06650579: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial

Recruiting
3
72
US
Abiraterone Acetate, BR9004, BR9004-1, CB 7630, CB-7630, CB7630, JNJ-212082, Yonsa, Zytiga, Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography Angiography, CT ANGIOGRAPHY, CT Scan Angiography, CTA, Leuprolide, Leuprorelin, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385
Emory University, Pfizer, Sumitomo Pharma America, Inc., National Comprehensive Cancer Network, National Cancer Institute (NCI)
Recurrent Prostate Carcinoma, Stage III Prostate Cancer AJCC V8, Stage IVA Prostate Cancer AJCC V8
07/29
07/29
ChiCTR2400083129: Study of Relugolix for Treatment of heavy menstrual bleeding associated with uterine fibroids

Not yet recruiting
3
180
 
Relugolix tablet administered orally once daily; Relugolix placebo administered orally once daily
Peking Union Medical College Hospital; Peking Union Medical College Hospital, Shanghai Huilun Pharmaceutical Co., Ltd
Heavy Menstrual Bleeding Associated with Uterine Fibroids
 
 
ChiCTR2400087806: A multi-center clinical trial to evaluate the efficacy and safety of Relugolix Tablets in the treatment of advanced adrogen-sensitive prostate cancer

Recruiting
3
110
 
Relugolix Tablets
Cancer Hospital, Chinese Academy of Medical Sciences; Jiangxi Shanxiang Pharmaceutical Co., Ltd., Jiangxi Shanxiang Pharmaceutical Co., Ltd.
advanced hormone-sensitive prostate cancer
 
 
REPLACE-CV, NCT05605964: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Completed
3
387
US
Relugolix, ORGOVYX, TAK-385, MVT-601, RVT-601, T-1331285, Leuprolide Acetate, Leuprolide
Sumitomo Pharma Switzerland GmbH
Prostate Cancer
01/25
01/25
NCT05862272: A Phase 3B Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Women with Uterine Fibroids or Endometriosis

Recruiting
3
1000
US
Relugolix Combination Tablet, TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE
Sumitomo Pharma Switzerland GmbH
Uterine Fibroids, Endometriosis
07/29
09/30
GUIDANCE, NCT05050084: Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Recruiting
3
2050
Canada, US
Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/26
11/26
INDICATE, NCT04423211: Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Recruiting
3
804
US
3-Dimensional Conformal Radiation Therapy, 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure), Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Degarelix, FE200486, Firmagon, External Beam Radiation Therapy, Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation, Fluciclovine F18, (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18, Goserelin Acetate, ZDX, Zoladex, Intensity-Modulated Proton Therapy, IMPT, Intensity-Modulated Radiation Therapy, IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy, Leuprolide Acetate, A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, TAK 385, TAK-385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation Therapy, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532, Detryptoreline, Volume Modulated Arc Therapy, VMAT, Volumetric Modulated Arc Therapy (procedure)
ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
12/32
12/32
PREDICT-RT, NCT04513717: Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The Trial

Recruiting
3
2753
Canada, US
Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Magnetic Resonance Elastography, MRE, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
12/33
12/33
COV19-DS, NCT03348670: Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms

Active, not recruiting
2/3
600
US
Abiraterone - Usual, ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral, Abiraterone - Study, ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Prostate Cancer
05/24
05/24
VA STARPORT, NCT04787744: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

Recruiting
2/3
464
US
PET-directed Local Therapy using Surgery, PET-directed Local Therapy using Radiation, Salvage Local Therapy for locally recurrent disease, Goserelin, Histrelin, Leuprolide & Triptorelin, ADT + Nilutamide, Flutamide, & Bicalutamide, Degarelix & Relugolix, ADT + Docetaxel +/- prednisone, ADT + Abiraterone + Prednisone, ADT + Abiraterone + Methylprednisolone, ADT + Apalutamide, ADT + Enzalutamide, Prostate-directed Radiation for De novo oligometastatic prostate cancer
VA Office of Research and Development
Prostate Cancer, Oligometastasis, Oligorecurrence, Recurrent Prostate Cancer, Metastatic Prostate Cancer, De Novo Prostate Cancer
07/25
12/25
Apa-RP, NCT04523207: A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

Completed
2
108
US
Apalutamide, JNJ-56021927, ADT, Relugolix
Janssen Research & Development, LLC
Prostatic Neoplasms
10/23
10/23
NCT06129851: Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer

Not yet recruiting
2
90
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Brachytherapy, Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy, Radiation, Internal, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Dual X-ray Absorptiometry, BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN, External Beam Radiation Therapy, Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, PSMA PET Scan, Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385
University of Kansas Medical Center, National Cancer Institute (NCI)
Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
10/25
10/26
NCT06279195: Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

Not yet recruiting
2
60
US
Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet, Myfembree, Relugolix Combination Therapy, REL-CT
NorthShore University HealthSystem, Pfizer
Pelvic Pain
08/25
08/25
NCT06397703: ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

Recruiting
2
392
US
Leuprolide, Degarelix or Relugolix, Stereotactic body radiation therapy/radiosurgery (SBRT)
NYU Langone Health
Prostate Cancer
04/30
04/31
REVELUTION, NCT05320406: RElugolix VErsus LeUprolide Cardiac Trial

Active, not recruiting
2
94
US
Radiation therapy, External beam radiation therapy, Intensity modulated radiation therapy, Proton therapy, Brachytherapy, Stereotactic body radiotherapy, Leuprolide, Leuprolide acetate, Lupron, Relugolix, Orgovyx, TAK-385
Emory University, National Cancer Institute (NCI), Prostate Cancer Foundation
Biochemically Recurrent Prostate Carcinoma, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
01/25
06/25
DIVINE, NCT06378866: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, Trial

Recruiting
2
220
US
Abiraterone, Abiraterone acetate, CB-7598, CB7598, Zytiga, Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography (CAT), Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Degarelix, ASP3550, FE200486, Firmagon, Enzalutamide, ASP9785, MDV3100, Xtandi, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, Nuclear Magnetic Resonance (NMR) Imaging, NMRI, Nuclear Magnetic Resonance Imaging (NMRI), sMRI, Structural MRI (sMRI), NMR Imaging, Patient Observation, Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography (PET), Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation (SABR), Stereotactic Ablative Body Radiation Therapy, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, AY25650, CL-118,532, CL118532, Detryptoreline
Mayo Clinic
Recurrent Castration-Sensitive Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8, Recurrent Prostate Cancer, Castration-resistant Prostate Cancer
05/29
05/29
NCT06330805: Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

Recruiting
2
70
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Contrast Agent, Contrast, Contrast Drugs, contrast material, Contrast Medium, Leuprolide, Leuprorelin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Physical Performance Testing, Physical Fitness Testing, Physical Function Testing, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385
Ohio State University Comprehensive Cancer Center, Pfizer, Myovant Sciences GmbH, Sumitomo Pharmaceuticals America
Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
12/27
12/27
NCT06499870: Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial

Recruiting
2
50
US
Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Enzalutamide, ASP9785, MDV 3100, MDV-3100, MDV3100, Xtandi, Fluorine F 18 Piflufolastat, 18F-DCFPyL, Fluorine F 18 DCFPyL, Piflufolastat F 18, Piflufolastat F-18, Piflufolastat F18, Pylarify, Image Guided Radiation Therapy, IGRT, image-guided radiation therapy, Image-Guided Radiotherapy, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385
Northwestern University, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/28
11/32
NRG PROMETHEAN, NCT05053152: Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

Recruiting
2
194
Canada, US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Fluciclovine F18, (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Placebo Administration, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, PSMA PET Scan, Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
NRG Oncology, National Cancer Institute (NCI)
Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Ductal Adenocarcinoma, Prostate Intraductal Carcinoma, Stage IVB Prostate Cancer AJCC v8
02/29
02/29
NCT06463457: Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Active, not recruiting
2
33
US
Darolutamide, ODM-201, Bay 1841788, C19H19CIN6O2, Relugolix, Orgovyx, RVT-601, TAK-385, 1-[4-[1-[(2,6-difluorophenyl)methyl]-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxothieno[2,3-d]pyrimidin-6-yl]phenyl]-3-methoxyurea, C29H27F2N7O5S
Atish Choudhury, MD, Bayer, Pfizer, National Comprehensive Cancer Network, Sumitomo Pharmaceuticals America
Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
11/28
11/28
NCT06734130: Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Recruiting
2
25
US
Luteinizing Hormone-Releasing Hormone (LHRH) analog, Degarelix, Leuprolide, Triptorelin, Relugolix, Androgen Receptor Signal Inhibitor (ARSI), Enzalutamide, Apalutamide, Darolutamide, Docetaxel
H. Lee Moffitt Cancer Center and Research Institute
Metastatic Castration Sensitive Prostate Cancer
01/27
01/27
NCT06528210: Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer

Recruiting
2
32
US
Gonadotropin Releasing Hormone Agonists and Antagonists, GnRH Antagonist, Gonadotropin Releasing Hormone Inhibitor, Leuprolide, Goserelin, Triptorelin, Degarelix, Relugolix, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Pembrolizumab, BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar QL2107, QL2107, SCH 900475, Questionnaire Administration, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Bone Scan, Bone Scintigraphy
OHSU Knight Cancer Institute, Merck Sharp & Dohme LLC, Oregon Health and Science University
High Risk Prostate Carcinoma, Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
06/26
06/28
NCT05189457: First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer

Active, not recruiting
2
32
US
Luteinizing Hormone Releasing Hormone, Leuprolide, Triptorelin, Goserslin, Relugolix, Degarelix, New Hormonal Agent, Abiraterone, Enzalutamide, Docetaxel, Tislelizumab, BGB-A317
H. Lee Moffitt Cancer Center and Research Institute, BeiGene
Prostate Cancer, Stage IV Prostate Cancer
07/27
07/28
NCT05765500: RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

Recruiting
2
110
US
Relugolix, Orgovyx, Leuprolide, Leuprolide Depot
Dana-Farber Cancer Institute, Prostate Cancer Foundation, Pfizer, Myovant Sciences GmbH
Prostate Cancer, Prostatic Neoplasms
07/25
01/26
EnrichPSMA, NCT07025369: Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The Trial

Not yet recruiting
2
30
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Flotufolastat F-18 Gallium, (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3, Fluorine F 18 Radiohybrid PSMA-7.3, Fluorine F 18 rhPSMA-7.3, Fluorine-18 rhPSMA-7.3, Posluma, rhPSMA-7.3 (18F), Laparoscopic Radical Prostatectomy with Robotics, RARP, Robot-assisted Radical Prostatectomy, Pelvic Lymphadenectomy, Excision Pelvic Lymph Nodes, Pelvic Lymph Node Dissection, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385
Mayo Clinic
Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
07/26
07/26
NCT06922318: The COSMYC Trial (COmbined Suppression of MYC)

Not yet recruiting
2
50
US
ZEN-3694, Testosterone cypionate, Enzalutamide, Luteinizing hormone-releasing hormone (LHRH) analogue, Zoladex, Trelstar, Eligard, Lupron, Degarelix, Relugolix
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Zenith Epigenetics, National Cancer Institute (NCI)
Metastatic Castration-resistant Prostate Cancer
08/31
08/31
APEX, NCT06059118: Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting
2
50
US
DFMO, eflornithine, difluoromethylornithine, testosterone cypionate, DEPO-Testosterone Injection, Luteinizing hormone-releasing hormone (LHRH) analogue, Zoladex, Trelstar, Eligard, Lupron, Degarelix, Relugolix, Enzalutamide, Xtandi
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Panbela Therapeutics, Prostate Cancer Foundation, United States Department of Defense
Prostate Cancer
01/26
11/29
NCT06111313: The University of Miami Adapt (UAdapt) Trial

Recruiting
2
130
US
FTLEAD, Ultra-Short-Term Androgen Deprivation Therapy with Relugolix, HypoLEAD, ADT Standard of Care
University of Miami, Varian Medical Systems
Prostate Cancer
11/28
11/33
NCT06111781: The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

Recruiting
2
60
US
Relugolix 120 MG [Orgovyx], SBRT standard of care radiotherapy treatment and Relugolix, SBRT standard of care radiotherapy treatment
Yale University, Pfizer
Prostate Cancer
02/28
02/28
OralT12, NCT06312761: Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17

Not yet recruiting
1/2
10
NA
Relugolix 120Mg Tab, Curcumin, Testosterone Undecanoate 237 MG Oral Capsule
University of Washington, Washington State University
Hypogonadism, Male
12/25
12/25
NCT04666129: Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Completed
1
48
US
Relugolix, MVT-601, TAK-385, T-1331285, RVT-601, Orgovyx, Abiraterone, Zytiga, Yonsa, Prednisone, Methylprednisolone, Medrol, Apalutamide, Erleada, Docetaxel, Docefrez, Taxotere
Sumitomo Pharma Switzerland GmbH
Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer
05/24
05/24
NCT06631521: Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Recruiting
1
30
US
Darolutamide, Nubeqa, BAY 1841788, Relugolix, Radical Prostatectomy
AdventHealth, Bayer, Sumitomo Pharma Switzerland
Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
06/26
06/26
NCT06130995: Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

Recruiting
1
46
US
Relugolix and Enzalutamide
University of Oklahoma, Pfizer, Astellas Pharma Inc
Androgen Deprivation Therapy, Locally Advanced Prostate Cancer
01/29
01/30
NCT05679388: A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients

Terminated
1
60
US
Relugolix Pill, Ritonavir, Itraconazole, Sporanox
University of Chicago
Prostate Cancer, Prostate Cancer Metastatic, Prostate Adenocarcinoma
08/24
08/24
ChiCTR2300074285: Randomised, double-blind, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of LY01021 single dose in healthy subjects

Not yet recruiting
1
120
 
Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Oral control Relugolix 40 mg; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Oral control Relugolix 40 mg
Clinical Trial Center of Third Xiangya Hospital of Central South University; Third Xiangya Hospital, Central South University, Yantai Chuanghe Biotechnology Co.
Prostate cancer requiring androgen depot therapy, endometriosis
 
 
NCT06462014: Description of Relugolix Use in Patients With Prostate Cancer Within the VHA

Completed
N/A
500
US
Relugolix
Pfizer
Prostate Cancer
12/24
12/24
MySaturn, NCT06953076: Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The Study

Not yet recruiting
N/A
111
NA
Relugolix/estradiol/norethisterone acetate, Ryeqo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Uterine Bleeding, Uterine Leiomyomas, Uterine Hemorrhage, Uterine Neoplasms
05/26
05/27
NCT05739136: MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

Not yet recruiting
N/A
530
NA
Relugolix + Estradiol + Norethindrone Acetate, MVT-601, MVT-601A, MYFEMBREE
Sumitomo Pharma Switzerland GmbH
Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
05/27
05/27
OPTYX, NCT05467176: A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX

Active, not recruiting
N/A
999
US
Relugolix, TAK-385, MVT-601, RVT-601, T-1331285, ORGOVYX
Sumitomo Pharma Switzerland GmbH
Prostate Cancer
05/28
05/28
NCT05739123: Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

Recruiting
N/A
728
US
Relugolix-Containing Product, TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE
Sumitomo Pharma Switzerland GmbH
Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
05/33
05/33
Esmya (ulipristal acetate) / ASKA Pharma, Gedeon Richter, AbbVie, Perrigo Company
2017-005120-16: Ulipristal versus surgery for symptomatic uterine fibroids Ulipristal (een medicijn) versus operatieve behandeling bij symptomatische vleesbomen in de baarmoeder.

Not yet recruiting
4
179
Europe
Esmya, Tablet, Esmya
Amsterdam UMC, Location VUmc, ZonMW
Uterine fibroids are very common during reproductive years in women. Minimally invasive treatments are emerging. Myomectomy is the gold standard, preferably laparoscpically, because it removes the fibroids entirely. Ulipristal, a selective progesterone receptor modulator, was introduced in 2012 as a new revolutionary (long-term) treatment for symptomatic uterine fibroids. It claims to make invasive treatment unnecessary. Myomen van de uterus komen veel voor. (Laparoscopische) myomectomie is de gouden standaard, gezien het feit dat de myomen in geheel wordt verwijderd. Ulipristal, een selectieve progesteron receptor modulator, is in 2012 op de markt gekomen als een nieuwe, revolutionaire (lange termijn) behandeling voor symptomatische uterine myomen. Het claimt invasieve behandeling te kunnen voorkomen., Uterine fibroids are very common. Sometimes surgical removal is necessary. However, ulipristal, a new medicine for treatment of symptomatic fibroids, claims to make invasive treatment unnecessary. Myomen (vleesbomen) van de baarmoeder komen veel voor. Soms is chirugische verwijdering noodzakelijk. Ulipristal is een nieuw medicijn dat beweert chirurgische behandeling te kunnen voorkomen., Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
NCT05674513: Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Recruiting
4
140
US
Ulipristal acetate
Oregon Health and Science University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contraceptive Usage
12/26
12/27
2014-003408-65: Comparison of drug ulipristal acetate with existing treatment of levonorgestrel-releasing intra-uterine system.

Ongoing
3
220
Europe
Ulipristal acetate, Levonorgestrel-releasing intra-uterine system, Tablet, , Esmya, Mirena
University of Edinburgh, NHS Lothian
Heavy menstrual bleeding, Heavy menstrual bleeding, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
NCT06727734: Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Not yet recruiting
3
980
NA
Levonorgestrel, Anlitin, Piroxicam, CP-Pirox, Ulipristal Acetate, Ella, Placebo - LNG, Placebo - Piroxicam, Placebo - UPA
The University of Hong Kong, The Family Planning Association of Hong Kong
Contraception
09/27
10/27
2013-005494-53: A Study of the Histological Changes within Ectopic Endometrial Tissue, in Subjects with Pelvic Endometriosis- Following Treatment with Ulipristal Acetate, a Selective Progesterone Receptor Modulator (SPRM).

Ongoing
2
20
Europe
Ulipristal Acetate (Esmya), Tablet, Esmya
Norfolk and Norwich University Hospitals NHS Foundation Trust, PregLem SA
Endometriosis, Endometriosis, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
2016-001719-19: Can a selective progesterone receptor modulator be used for treatment of premenstrual dysphoric disorder? Kan en selektiv progesteronreceptor-modulerare användas för behandling av premenstruell dysfori?

Ongoing
2
100
Europe
esmya, Tablet, Esmya
Uppsala University, Uppsala University
Premenstrual dysphoric disorder Premenstruell dysfori, Premenstrual dysphoric disorder Premenstruell dysfori, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
BC-APPS1, NCT02408770 / 2015-001587-19: Breast Cancer - Anti-Progestin Prevention Study 1

Completed
2
24
Europe
ulipristal acetate, Esmya
Manchester University NHS Foundation Trust, University of Manchester
Breast Cancer
03/19
01/23
NCT05216952: Ulipristal Acetate for Use in Early Pregnancy Loss

Completed
2
3
US
Ulipristal Acetate Tablets, Ella, Misoprostol Pill, Cytotec
University of North Carolina, Chapel Hill, North Carolina Translational and Clinical Sciences Institute
Missed Abortion, Anembryonic Pregnancy, Non-Viable Pregnancy
01/23
04/23
NCT04291001: Ovarian Function With ENG Implant and UPA Use

Completed
1
40
US
ENG implant, Nexplanon, oral ulipristal acetate, Ella
University of Utah, Merck Sharp & Dohme LLC
Contraception
10/22
01/24
Premium, NCT02748460: Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

Active, not recruiting
N/A
1500
Europe, RoW
PregLem SA
Uterine Fibroids
12/22
12/22
NCT05285605: Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy

Completed
N/A
75
US
Ulipristal Acetate, Ella
Northwestern University, Society of Family Planning
Contraception, Contraceptive Usage, Reproductive Issues
03/23
01/24
NCT04028986: Esmya Versus Surgery Before IVF/ICSI

Active, not recruiting
N/A
40
Europe
Ulipristal Acetate 5 MG Oral Tablet, surgery for fibroid
Universitair Ziekenhuis Brussel
Fibroid; Uterus Tumor, Complicating Pregnancy, Infertility, Female, Surgical Procedure, Unspecified
12/25
06/26
Terrosa (teriparatide biosimilar) / Mochida, Gedeon Richter
2018-003888-56: Diagnosis and treatment of bone disease in patients with chronic kidney disease

Not yet recruiting
4
66
Europe
Solution for injection, Terrosa 20 micrograms/80 microliters solution for injection
Department of Nephrology, Herlev & Gentofte Hospital, Herlev Hospital, Augustinusfonden, Helen & Ejnar Bjoernows Fond, Danish Society of Nephrology, Herlev & Gentofte Hospital
Bone disease with low activity of the boneforming cells, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
DANDYNAMIC BONE, NCT04522622: Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

Recruiting
4
48
Europe
Teriparatide, Terrosa, DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT, Bone biopsy, Cardiac tests, Blood and urine samples and physical examination
Ditte Hansen, Odense University Hospital, Steno Diabetes Center Copenhagen, Rigshospitalet, Denmark, Aalborg University Hospital
Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease, Chronic Kidney Disease-Mineral and Bone Disorder
09/26
09/27
2018-002130-20: Study of Teriparatide in Stress Fracture Healing: RETURN

Not yet recruiting
3
136
Europe
Terrosa, FORSTEO, Suspension for injection in cartridge, Solution for injection in pre-filled pen, Terrosa, FORSTEO
Norfolk and Norwich University Hospitals NHS Foundation Trust
Healthy individuals with stress fractures., Healthy individuals with stress fractures., Body processes [G] - Bones and nerves physological processes [G11]
 
 
Bemfola (follitropin alfa biosimilar) / Gedeon Richter
2012-003412-31: Fertility preservation in breast cancer patients: oocytes or embryos vitrification. Préservation de la fertilité chez les patientes atteintes de cancer du sein : vitrification des ovocytes ou des embryons.

Ongoing
4
54
Europe
Letrozole, hormone folliculo–stimulante humaine recombinante, cetrorelix acetate, menotrophine, follitropine alfa, Film-coated tablet, Solution for injection in pre-filled pen, Powder and solvent for solution for injection, Concentrate and solvent for suspension for injection, Femara, Gonal-f 300IU, Gonal-f 900IU, Cétrotide, Menopur 75IU, Decapeptyl 0,1mg, Bemfola 150UI/0,25 ml, Bemfola 225 UI/0,375ml, Bemfola 300 UI/0,375ml
CUB - Hôpital Erasme, CUB - Hôpital Erasme
The aim of this trial is to offer a safe and efficient alternative protocol to preserve fertility by storing oocytes in breast cancer patients before chemotherapy. Letrozole, an inhibitor of aromatase, is administered during standard gonadotropins ovarian stimulation to maintain a low estradiol level during ovarian stimulation in patients with hormono-sensitive tumour., Letrozole is associated with standard ovarian stimulation in order preserve fertility by storing oocytes/embryos in breast cancer patients before chemotherapy by maintaining low estradiol level., Diseases [C] - Cancer [C04]
 
 
2020-001218-39: Estradiol levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer (FET) cycle Østradiol-niveauer i tidlig graviditet efter naturlig, østradiol + progesteron eller gonadotropin-stimuleret frysecyklus.

Not yet recruiting
4
300
Europe
estradiol, bemfola, cyclogest, ovitrelle, 30158EU/1/00/165/007( marketing code), Tablet, Solution for injection/infusion, Vaginal tablet, Suspension for injection in pre-filled pen, Estradiol, bemfola, Cyclogest, ovitrelle
fertility clinic, Herlev university hospital, Fertilti clinic Hvidovre University hospital, Fertility clinic Herlev University Hospital, Fertility clinic Hvidovre University Hospital
Infertile women Infertile kvinder, Infertile women Ufrivilligt barnløse kvinder, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
NCT05103228: Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders

Completed
N/A
190
Europe
Follitropin Alfa, Ovaleap (Theramex Ireland Limited), Bemfola (Richter Gedeon Nyrt., Hungary), Gonal F (Merck Europe B.V.), Follitropin delta, Rekovelle (Ferring Pharmaceuticals A/S, Denmark), human menopausal gonadotropin, Menopur (Ferring Pharmaceuticals A/S, Denmark)
Peter Kovacs MD
Infertility, Ovarian Dysfunction
07/23
07/23
ACTRN12618000728235: A patient satisfaction evaluation study of Bemfola (recombinant FSH) administered with a 12mm needle or a 4mm needle in the treatment of subjects undergoing invitro fertilisation (IVF)

Recruiting
N/A
112
 
Dr Rachael Knight, Gedeon Richter Australia Pty Ltd
Reproductive Health and Childbirth, Invitro Fertilization, Infertility
 
 
Starjemza (ustekinumab-hmny) / Dr. Reddy’s, Bio-Thera Solutions, Pharmapark, Hikma, Biomm, Gedeon Richter, Astra Industrial Group
NCT04728360 / 2020-004504-33: Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

Completed
3
556
RoW
BAT2206, Stelara (EU-sourced)
Bio-Thera Solutions, Bio-Thera Solutions, Ltd.
Plaque Psoriasis
10/22
07/23
2020-004504-33: Study to Compare Efficacy and Safety of BAT2206 with Stelara® in Patients with Moderate to Severe Plaque Psoriasis

Not yet recruiting
3
556
Europe
Recombinant Human Anti-IL12 Monoclonal Antibody, BAT2206, Solution for injection in pre-filled syringe, Stelara®
Bio-Thera Solutions, Ltd., Bio-Thera Solutions, Ltd.
Moderate to Severe Plaque Psoriasis, chronic autoimmune disorder that causes the excessive buildup of skin cells, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
ChiCTR2000030273: A Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects

Not yet recruiting
1
270
 
BAT2206 injection, 45mg; Stelara (EU-licensed); 45mg; Stelara (US-licensed), 45mg
The First Hospital of Jinlin University; Bio-thera Solutions, Ltd., Self-finance
Psoriasis
 
 
RGB-14-P (denosumab biosimilar) / Gedeon Richter
NCT05087030 / 2020-006017-38: Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

Completed
3
473
Europe, US, RoW
RGB-14-P, Prolia®
Gedeon Richter Plc.
Postmenopausal Osteoporosis
10/23
11/23
LusiNEX (tocilizumab biosimilar) / Gedeon Richter, Mochida
ACTRN12618000859280: Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)

Active, not recruiting
1
190
 
Mycenax Biotech Inc., Mycenax Biotech Inc.
Elevated liver enzymes, neutropenia, thrombocytopenia
 
 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Vraylar (cariprazine) / Mitsubishi Tanabe, Recordati, Gedeon Richter, AbbVie
2020-005726-29: An open label signal detection study to evaluate the effects of cariprazine on cognitive functioning in patients with schizophrenia in need of adjustment of oral antipsychotic treatment

Not yet recruiting
4
20
Europe
Capsule, hard, Reagila
Medical University Innsbruck, Gedeon Richter Plc.
Schizophrenia, Schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2021-001268-58: Investigation of effects of cariprazine in patients with mitochondrial schizophrenia A cariprazine hatásának vizsgálata mitochondriális dysfunkcióval asszociált schizophreniában

Not yet recruiting
4
10
Europe
Reagila, Capsule, Reagila
Semmelweis University, STIA-POC-2020, Semmelweis University, STIA-POC-2020, Gedeon Richter
Mitochondrial disease associated schizophrenia Mitochondrialis betegséghez társuló schizophrenia, schizophrenia associating with mitochondrial disease schizophrenia, amely mitochondrialis betegséghez társul, Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
 
 
2021-006706-69: Lithium versus cariprazine in the treatment of bipolar depression

Not yet recruiting
4
122
Europe
Cariprazine, lithium citrate, Capsule, hard, Tablet, Reagila, Litarex
Psychiatry – Aalborg University Hospital, Unit for Psychiatric Research, Danske Regioner, Region Nordjylland
Bipolar disorder, current depressive episode. -Bipolar affektiv lidelse, aktuel depressiv episode, Patients with a diagnoses of bipolar disorder who have a depressive episode, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT04843423: Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder

Recruiting
4
15
Canada
Cariprazine
Dr. Martin A. Katzman
Attention Deficit Hyperactivity Disorder
12/22
04/23
NCT05384483: Cariprazine Versus Placebo for Social Anxiety Disorder

Completed
4
40
US
Cariprazine, Vraylar®, Placebo
The Medical Research Network, AbbVie
Social Anxiety Disorder
04/24
04/24
DUAG9, NCT05913947 / 2021-006706-69: Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression

Recruiting
4
122
Europe
Lithium, Litarex, ATC; N05AN01, Cariprazine, Reagila, ATC: N05AX15
Aalborg University Hospital, Mental Health Center, Glostrup, Mental Health Center North Zealand, Mental Health Department Odense, University Clinic, Psychiatric Center Copenhagen, Rigshospitalet
Depression, Bipolar
09/24
09/24
SMART-BD, NCT06433635: Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Recruiting
4
2726
Canada, US
Cariprazine, Vraylar, Aripiprazole/Escitalopram combination, Abilify/ Lexapro, Quetiapine, Seroquel, Lurasidone, Latuda
Massachusetts General Hospital, Patient-Centered Outcomes Research Institute
Bipolar I Disorder, Depression
02/30
02/30
NCT05060549: Dopamine D3 Receptor Occupancy in Bipolar Depression

Not yet recruiting
4
8
US
Cariprazine, Vraylar
New York State Psychiatric Institute
Bipolar Depression
12/26
12/26
NCT05741502: An Exploratory Analysis of Immune and Inflammatory Response Associated with Clozapine

Recruiting
4
60
US
Clozapine, Antipsychotics,Other (non-Clozapine), Including Olanzapine, Risperidone, Paliperidone, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, and all Typical antipsychotics
Ohio State University
Treatment-resistant Schizophrenia
03/26
06/26
NCT05933538: Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

Not yet recruiting
4
110
NA
Cariprazine, Treatment as usual
Sultan Qaboos University
Depressive Disorder, Major
08/30
12/30
2018-004590-27: Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia

Ongoing
3
300
Europe
cariprazine, RGH-188, Capsule, hard, Reagila
Gedeon Richter Plc, Gedeon Richter Plc
Adolescent patient (13-<18 years of age) with Schizophrenia, Adolescent patient (13-<18 years of age) with Schizophrenia, Diseases [C] - Nervous System Diseases [C10]
 
 
2018-004006-26: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 years of age) with Schizophrenia

Ongoing
3
330
Europe
cariprazine, RGH-188, Capsule, hard
Allergan Ltd, Allergan Ltd.
Adolescent Patients (13 to 17 years of age) with Schizophrenia, Adolescent Patients (13 to 17 years of age) with Schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2018-003164-31: The purpose of this study is to look into the safety and efficacy ofcariprazine as an add-on medication in the treatment of major depressivedisorder.

Not yet recruiting
3
750
RoW, Europe
Cariprazine, Capsule
Allergan Ltd., Allergan Sales LLC
Major Depressive Disorder, Clinical Depression, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT04519099 / 2017-000818-34: Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

Recruiting
3
345
Europe, US, RoW
Cariprazine, Placebo
Allergan, Allergan Ltd
Schizophrenia
04/22
04/22
NCT05168007: Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

Enrolling by invitation
3
342
RoW
WID-RGC20(Cariprazine) 3mg/day, WID-RGC20(Cariprazine) 6mg/day, Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
Whanin Pharmaceutical Company
Schizophrenia
07/23
07/23
NCT05439616: Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD

Completed
3
161
US
Cariprazine, VRAYLAR, AGN-241780, Placebo
AbbVie
Autism Spectrum Disorder
10/24
10/24
NCT04777357: A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

Recruiting
3
380
US, RoW
Cariprazine, Vraylar, Placebo
AbbVie
Depression, Bipolar I Disorder
03/27
03/27
NCT03817502 / 2018-004006-26: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Recruiting
3
330
Europe, US, RoW
Cariprazine, Placebo
Gedeon Richter Plc., Allergan Ltd.
Schizophrenia
04/25
04/25
NCT05368558: Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia

Terminated
3
34
Japan, RoW
Cariprazine, VRAYLAR, Placebo
AbbVie
Schizophrenia
09/24
09/24
NCT04578756: Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

Active, not recruiting
3
310
US
Cariprazine Flexible Dose
AbbVie
Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD)
09/25
09/25
CARPZ-01, NCT04771299: Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients

Terminated
3
1
Canada
Cariprazine, VRAYLAR®, Placebo
Lakshmi N Yatham
Bipolar I Disorder, Cognitive Impairment
09/24
09/24
NCT05063201: Cariprazine for Comorbid Cocaine and Opioid Use Disorder

Recruiting
2
48
US
Cariprazine 1.5 MG, Placebo
Kyle Kampman, National Institute on Drug Abuse (NIDA)
Opioid-use Disorder, Cocaine Use Disorder
12/25
12/25
CReW BP-I, NCT06256367: Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder

Recruiting
N/A
170
Canada, US
AbbVie
Bipolar I Disorder
07/25
07/25
Orgovyx (relugolix) / Takeda, Sumitomo Pharma, Pfizer
SPIRIT EXTENSION, NCT03654274 / 2017-004066-10: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

Completed
3
802
Europe, Canada, US, RoW
Relugolix, TAK-385, MVT-601, Estradiol/norethindrone acetate, E2/NETA, low-dose hormonal add-back
Myovant Sciences GmbH
Endometriosis
12/21
01/23
SERENE, NCT04756037: Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

Active, not recruiting
3
1020
US
Relugolix Combination Therapy, Myfembree
Sumitomo Pharma Switzerland GmbH
Contraception
02/25
02/26
NCT06439524: The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial

Recruiting
3
110
US
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, Relugolix Combination Therapy (Rel-CT), Myfembree
Main Line Health, Pfizer, Sumitomo Pharma Switzerland GmbH
Endometriosis
02/26
08/26
NCT06671548: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Not yet recruiting
3
120
RoW
Relugolix, megestrol acetate, medroxyprogesterone acetate, Relugolix placebo, megestrol acetate placebo, medroxyprogesterone acetate placebo
Qilu Pharmaceutical Co., Ltd.
Heavy Menstrual Bleeding, Uterine Fibroids
12/26
02/27
REVELUTION-2, NCT06650579: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial

Recruiting
3
72
US
Abiraterone Acetate, BR9004, BR9004-1, CB 7630, CB-7630, CB7630, JNJ-212082, Yonsa, Zytiga, Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography Angiography, CT ANGIOGRAPHY, CT Scan Angiography, CTA, Leuprolide, Leuprorelin, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385
Emory University, Pfizer, Sumitomo Pharma America, Inc., National Comprehensive Cancer Network, National Cancer Institute (NCI)
Recurrent Prostate Carcinoma, Stage III Prostate Cancer AJCC V8, Stage IVA Prostate Cancer AJCC V8
07/29
07/29
ChiCTR2400083129: Study of Relugolix for Treatment of heavy menstrual bleeding associated with uterine fibroids

Not yet recruiting
3
180
 
Relugolix tablet administered orally once daily; Relugolix placebo administered orally once daily
Peking Union Medical College Hospital; Peking Union Medical College Hospital, Shanghai Huilun Pharmaceutical Co., Ltd
Heavy Menstrual Bleeding Associated with Uterine Fibroids
 
 
ChiCTR2400087806: A multi-center clinical trial to evaluate the efficacy and safety of Relugolix Tablets in the treatment of advanced adrogen-sensitive prostate cancer

Recruiting
3
110
 
Relugolix Tablets
Cancer Hospital, Chinese Academy of Medical Sciences; Jiangxi Shanxiang Pharmaceutical Co., Ltd., Jiangxi Shanxiang Pharmaceutical Co., Ltd.
advanced hormone-sensitive prostate cancer
 
 
REPLACE-CV, NCT05605964: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Completed
3
387
US
Relugolix, ORGOVYX, TAK-385, MVT-601, RVT-601, T-1331285, Leuprolide Acetate, Leuprolide
Sumitomo Pharma Switzerland GmbH
Prostate Cancer
01/25
01/25
NCT05862272: A Phase 3B Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Women with Uterine Fibroids or Endometriosis

Recruiting
3
1000
US
Relugolix Combination Tablet, TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE
Sumitomo Pharma Switzerland GmbH
Uterine Fibroids, Endometriosis
07/29
09/30
GUIDANCE, NCT05050084: Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Recruiting
3
2050
Canada, US
Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/26
11/26
INDICATE, NCT04423211: Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Recruiting
3
804
US
3-Dimensional Conformal Radiation Therapy, 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure), Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Degarelix, FE200486, Firmagon, External Beam Radiation Therapy, Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation, Fluciclovine F18, (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18, Goserelin Acetate, ZDX, Zoladex, Intensity-Modulated Proton Therapy, IMPT, Intensity-Modulated Radiation Therapy, IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy, Leuprolide Acetate, A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, TAK 385, TAK-385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation Therapy, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532, Detryptoreline, Volume Modulated Arc Therapy, VMAT, Volumetric Modulated Arc Therapy (procedure)
ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
12/32
12/32
PREDICT-RT, NCT04513717: Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The Trial

Recruiting
3
2753
Canada, US
Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Magnetic Resonance Elastography, MRE, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
12/33
12/33
COV19-DS, NCT03348670: Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms

Active, not recruiting
2/3
600
US
Abiraterone - Usual, ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral, Abiraterone - Study, ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Prostate Cancer
05/24
05/24
VA STARPORT, NCT04787744: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

Recruiting
2/3
464
US
PET-directed Local Therapy using Surgery, PET-directed Local Therapy using Radiation, Salvage Local Therapy for locally recurrent disease, Goserelin, Histrelin, Leuprolide & Triptorelin, ADT + Nilutamide, Flutamide, & Bicalutamide, Degarelix & Relugolix, ADT + Docetaxel +/- prednisone, ADT + Abiraterone + Prednisone, ADT + Abiraterone + Methylprednisolone, ADT + Apalutamide, ADT + Enzalutamide, Prostate-directed Radiation for De novo oligometastatic prostate cancer
VA Office of Research and Development
Prostate Cancer, Oligometastasis, Oligorecurrence, Recurrent Prostate Cancer, Metastatic Prostate Cancer, De Novo Prostate Cancer
07/25
12/25
Apa-RP, NCT04523207: A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

Completed
2
108
US
Apalutamide, JNJ-56021927, ADT, Relugolix
Janssen Research & Development, LLC
Prostatic Neoplasms
10/23
10/23
NCT06129851: Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer

Not yet recruiting
2
90
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Brachytherapy, Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy, Radiation, Internal, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Dual X-ray Absorptiometry, BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN, External Beam Radiation Therapy, Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, PSMA PET Scan, Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385
University of Kansas Medical Center, National Cancer Institute (NCI)
Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
10/25
10/26
NCT06279195: Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

Not yet recruiting
2
60
US
Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet, Myfembree, Relugolix Combination Therapy, REL-CT
NorthShore University HealthSystem, Pfizer
Pelvic Pain
08/25
08/25
NCT06397703: ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

Recruiting
2
392
US
Leuprolide, Degarelix or Relugolix, Stereotactic body radiation therapy/radiosurgery (SBRT)
NYU Langone Health
Prostate Cancer
04/30
04/31
REVELUTION, NCT05320406: RElugolix VErsus LeUprolide Cardiac Trial

Active, not recruiting
2
94
US
Radiation therapy, External beam radiation therapy, Intensity modulated radiation therapy, Proton therapy, Brachytherapy, Stereotactic body radiotherapy, Leuprolide, Leuprolide acetate, Lupron, Relugolix, Orgovyx, TAK-385
Emory University, National Cancer Institute (NCI), Prostate Cancer Foundation
Biochemically Recurrent Prostate Carcinoma, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
01/25
06/25
DIVINE, NCT06378866: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, Trial

Recruiting
2
220
US
Abiraterone, Abiraterone acetate, CB-7598, CB7598, Zytiga, Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography (CAT), Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Degarelix, ASP3550, FE200486, Firmagon, Enzalutamide, ASP9785, MDV3100, Xtandi, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, Nuclear Magnetic Resonance (NMR) Imaging, NMRI, Nuclear Magnetic Resonance Imaging (NMRI), sMRI, Structural MRI (sMRI), NMR Imaging, Patient Observation, Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography (PET), Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation (SABR), Stereotactic Ablative Body Radiation Therapy, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, AY25650, CL-118,532, CL118532, Detryptoreline
Mayo Clinic
Recurrent Castration-Sensitive Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8, Recurrent Prostate Cancer, Castration-resistant Prostate Cancer
05/29
05/29
NCT06330805: Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

Recruiting
2
70
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Contrast Agent, Contrast, Contrast Drugs, contrast material, Contrast Medium, Leuprolide, Leuprorelin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Physical Performance Testing, Physical Fitness Testing, Physical Function Testing, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385
Ohio State University Comprehensive Cancer Center, Pfizer, Myovant Sciences GmbH, Sumitomo Pharmaceuticals America
Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
12/27
12/27
NCT06499870: Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial

Recruiting
2
50
US
Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Enzalutamide, ASP9785, MDV 3100, MDV-3100, MDV3100, Xtandi, Fluorine F 18 Piflufolastat, 18F-DCFPyL, Fluorine F 18 DCFPyL, Piflufolastat F 18, Piflufolastat F-18, Piflufolastat F18, Pylarify, Image Guided Radiation Therapy, IGRT, image-guided radiation therapy, Image-Guided Radiotherapy, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385
Northwestern University, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/28
11/32
NRG PROMETHEAN, NCT05053152: Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

Recruiting
2
194
Canada, US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Fluciclovine F18, (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Placebo Administration, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, PSMA PET Scan, Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
NRG Oncology, National Cancer Institute (NCI)
Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Ductal Adenocarcinoma, Prostate Intraductal Carcinoma, Stage IVB Prostate Cancer AJCC v8
02/29
02/29
NCT06463457: Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Active, not recruiting
2
33
US
Darolutamide, ODM-201, Bay 1841788, C19H19CIN6O2, Relugolix, Orgovyx, RVT-601, TAK-385, 1-[4-[1-[(2,6-difluorophenyl)methyl]-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxothieno[2,3-d]pyrimidin-6-yl]phenyl]-3-methoxyurea, C29H27F2N7O5S
Atish Choudhury, MD, Bayer, Pfizer, National Comprehensive Cancer Network, Sumitomo Pharmaceuticals America
Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
11/28
11/28
NCT06734130: Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Recruiting
2
25
US
Luteinizing Hormone-Releasing Hormone (LHRH) analog, Degarelix, Leuprolide, Triptorelin, Relugolix, Androgen Receptor Signal Inhibitor (ARSI), Enzalutamide, Apalutamide, Darolutamide, Docetaxel
H. Lee Moffitt Cancer Center and Research Institute
Metastatic Castration Sensitive Prostate Cancer
01/27
01/27
NCT06528210: Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer

Recruiting
2
32
US
Gonadotropin Releasing Hormone Agonists and Antagonists, GnRH Antagonist, Gonadotropin Releasing Hormone Inhibitor, Leuprolide, Goserelin, Triptorelin, Degarelix, Relugolix, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Pembrolizumab, BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar QL2107, QL2107, SCH 900475, Questionnaire Administration, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Bone Scan, Bone Scintigraphy
OHSU Knight Cancer Institute, Merck Sharp & Dohme LLC, Oregon Health and Science University
High Risk Prostate Carcinoma, Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
06/26
06/28
NCT05189457: First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer

Active, not recruiting
2
32
US
Luteinizing Hormone Releasing Hormone, Leuprolide, Triptorelin, Goserslin, Relugolix, Degarelix, New Hormonal Agent, Abiraterone, Enzalutamide, Docetaxel, Tislelizumab, BGB-A317
H. Lee Moffitt Cancer Center and Research Institute, BeiGene
Prostate Cancer, Stage IV Prostate Cancer
07/27
07/28
NCT05765500: RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

Recruiting
2
110
US
Relugolix, Orgovyx, Leuprolide, Leuprolide Depot
Dana-Farber Cancer Institute, Prostate Cancer Foundation, Pfizer, Myovant Sciences GmbH
Prostate Cancer, Prostatic Neoplasms
07/25
01/26
EnrichPSMA, NCT07025369: Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The Trial

Not yet recruiting
2
30
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Flotufolastat F-18 Gallium, (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3, Fluorine F 18 Radiohybrid PSMA-7.3, Fluorine F 18 rhPSMA-7.3, Fluorine-18 rhPSMA-7.3, Posluma, rhPSMA-7.3 (18F), Laparoscopic Radical Prostatectomy with Robotics, RARP, Robot-assisted Radical Prostatectomy, Pelvic Lymphadenectomy, Excision Pelvic Lymph Nodes, Pelvic Lymph Node Dissection, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385
Mayo Clinic
Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
07/26
07/26
NCT06922318: The COSMYC Trial (COmbined Suppression of MYC)

Not yet recruiting
2
50
US
ZEN-3694, Testosterone cypionate, Enzalutamide, Luteinizing hormone-releasing hormone (LHRH) analogue, Zoladex, Trelstar, Eligard, Lupron, Degarelix, Relugolix
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Zenith Epigenetics, National Cancer Institute (NCI)
Metastatic Castration-resistant Prostate Cancer
08/31
08/31
APEX, NCT06059118: Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting
2
50
US
DFMO, eflornithine, difluoromethylornithine, testosterone cypionate, DEPO-Testosterone Injection, Luteinizing hormone-releasing hormone (LHRH) analogue, Zoladex, Trelstar, Eligard, Lupron, Degarelix, Relugolix, Enzalutamide, Xtandi
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Panbela Therapeutics, Prostate Cancer Foundation, United States Department of Defense
Prostate Cancer
01/26
11/29
NCT06111313: The University of Miami Adapt (UAdapt) Trial

Recruiting
2
130
US
FTLEAD, Ultra-Short-Term Androgen Deprivation Therapy with Relugolix, HypoLEAD, ADT Standard of Care
University of Miami, Varian Medical Systems
Prostate Cancer
11/28
11/33
NCT06111781: The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

Recruiting
2
60
US
Relugolix 120 MG [Orgovyx], SBRT standard of care radiotherapy treatment and Relugolix, SBRT standard of care radiotherapy treatment
Yale University, Pfizer
Prostate Cancer
02/28
02/28
OralT12, NCT06312761: Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17

Not yet recruiting
1/2
10
NA
Relugolix 120Mg Tab, Curcumin, Testosterone Undecanoate 237 MG Oral Capsule
University of Washington, Washington State University
Hypogonadism, Male
12/25
12/25
NCT04666129: Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Completed
1
48
US
Relugolix, MVT-601, TAK-385, T-1331285, RVT-601, Orgovyx, Abiraterone, Zytiga, Yonsa, Prednisone, Methylprednisolone, Medrol, Apalutamide, Erleada, Docetaxel, Docefrez, Taxotere
Sumitomo Pharma Switzerland GmbH
Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer
05/24
05/24
NCT06631521: Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Recruiting
1
30
US
Darolutamide, Nubeqa, BAY 1841788, Relugolix, Radical Prostatectomy
AdventHealth, Bayer, Sumitomo Pharma Switzerland
Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
06/26
06/26
NCT06130995: Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

Recruiting
1
46
US
Relugolix and Enzalutamide
University of Oklahoma, Pfizer, Astellas Pharma Inc
Androgen Deprivation Therapy, Locally Advanced Prostate Cancer
01/29
01/30
NCT05679388: A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients

Terminated
1
60
US
Relugolix Pill, Ritonavir, Itraconazole, Sporanox
University of Chicago
Prostate Cancer, Prostate Cancer Metastatic, Prostate Adenocarcinoma
08/24
08/24
ChiCTR2300074285: Randomised, double-blind, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of LY01021 single dose in healthy subjects

Not yet recruiting
1
120
 
Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Oral control Relugolix 40 mg; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Randomised in a 4:1 ratio to use trial drug and placebo; Oral control Relugolix 40 mg
Clinical Trial Center of Third Xiangya Hospital of Central South University; Third Xiangya Hospital, Central South University, Yantai Chuanghe Biotechnology Co.
Prostate cancer requiring androgen depot therapy, endometriosis
 
 
NCT06462014: Description of Relugolix Use in Patients With Prostate Cancer Within the VHA

Completed
N/A
500
US
Relugolix
Pfizer
Prostate Cancer
12/24
12/24
MySaturn, NCT06953076: Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The Study

Not yet recruiting
N/A
111
NA
Relugolix/estradiol/norethisterone acetate, Ryeqo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Uterine Bleeding, Uterine Leiomyomas, Uterine Hemorrhage, Uterine Neoplasms
05/26
05/27
NCT05739136: MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

Not yet recruiting
N/A
530
NA
Relugolix + Estradiol + Norethindrone Acetate, MVT-601, MVT-601A, MYFEMBREE
Sumitomo Pharma Switzerland GmbH
Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
05/27
05/27
OPTYX, NCT05467176: A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX

Active, not recruiting
N/A
999
US
Relugolix, TAK-385, MVT-601, RVT-601, T-1331285, ORGOVYX
Sumitomo Pharma Switzerland GmbH
Prostate Cancer
05/28
05/28
NCT05739123: Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

Recruiting
N/A
728
US
Relugolix-Containing Product, TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE
Sumitomo Pharma Switzerland GmbH
Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
05/33
05/33
Esmya (ulipristal acetate) / ASKA Pharma, Gedeon Richter, AbbVie, Perrigo Company
2017-005120-16: Ulipristal versus surgery for symptomatic uterine fibroids Ulipristal (een medicijn) versus operatieve behandeling bij symptomatische vleesbomen in de baarmoeder.

Not yet recruiting
4
179
Europe
Esmya, Tablet, Esmya
Amsterdam UMC, Location VUmc, ZonMW
Uterine fibroids are very common during reproductive years in women. Minimally invasive treatments are emerging. Myomectomy is the gold standard, preferably laparoscpically, because it removes the fibroids entirely. Ulipristal, a selective progesterone receptor modulator, was introduced in 2012 as a new revolutionary (long-term) treatment for symptomatic uterine fibroids. It claims to make invasive treatment unnecessary. Myomen van de uterus komen veel voor. (Laparoscopische) myomectomie is de gouden standaard, gezien het feit dat de myomen in geheel wordt verwijderd. Ulipristal, een selectieve progesteron receptor modulator, is in 2012 op de markt gekomen als een nieuwe, revolutionaire (lange termijn) behandeling voor symptomatische uterine myomen. Het claimt invasieve behandeling te kunnen voorkomen., Uterine fibroids are very common. Sometimes surgical removal is necessary. However, ulipristal, a new medicine for treatment of symptomatic fibroids, claims to make invasive treatment unnecessary. Myomen (vleesbomen) van de baarmoeder komen veel voor. Soms is chirugische verwijdering noodzakelijk. Ulipristal is een nieuw medicijn dat beweert chirurgische behandeling te kunnen voorkomen., Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
NCT05674513: Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Recruiting
4
140
US
Ulipristal acetate
Oregon Health and Science University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contraceptive Usage
12/26
12/27
2014-003408-65: Comparison of drug ulipristal acetate with existing treatment of levonorgestrel-releasing intra-uterine system.

Ongoing
3
220
Europe
Ulipristal acetate, Levonorgestrel-releasing intra-uterine system, Tablet, , Esmya, Mirena
University of Edinburgh, NHS Lothian
Heavy menstrual bleeding, Heavy menstrual bleeding, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
NCT06727734: Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Not yet recruiting
3
980
NA
Levonorgestrel, Anlitin, Piroxicam, CP-Pirox, Ulipristal Acetate, Ella, Placebo - LNG, Placebo - Piroxicam, Placebo - UPA
The University of Hong Kong, The Family Planning Association of Hong Kong
Contraception
09/27
10/27
2013-005494-53: A Study of the Histological Changes within Ectopic Endometrial Tissue, in Subjects with Pelvic Endometriosis- Following Treatment with Ulipristal Acetate, a Selective Progesterone Receptor Modulator (SPRM).

Ongoing
2
20
Europe
Ulipristal Acetate (Esmya), Tablet, Esmya
Norfolk and Norwich University Hospitals NHS Foundation Trust, PregLem SA
Endometriosis, Endometriosis, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
2016-001719-19: Can a selective progesterone receptor modulator be used for treatment of premenstrual dysphoric disorder? Kan en selektiv progesteronreceptor-modulerare användas för behandling av premenstruell dysfori?

Ongoing
2
100
Europe
esmya, Tablet, Esmya
Uppsala University, Uppsala University
Premenstrual dysphoric disorder Premenstruell dysfori, Premenstrual dysphoric disorder Premenstruell dysfori, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
BC-APPS1, NCT02408770 / 2015-001587-19: Breast Cancer - Anti-Progestin Prevention Study 1

Completed
2
24
Europe
ulipristal acetate, Esmya
Manchester University NHS Foundation Trust, University of Manchester
Breast Cancer
03/19
01/23
NCT05216952: Ulipristal Acetate for Use in Early Pregnancy Loss

Completed
2
3
US
Ulipristal Acetate Tablets, Ella, Misoprostol Pill, Cytotec
University of North Carolina, Chapel Hill, North Carolina Translational and Clinical Sciences Institute
Missed Abortion, Anembryonic Pregnancy, Non-Viable Pregnancy
01/23
04/23
NCT04291001: Ovarian Function With ENG Implant and UPA Use

Completed
1
40
US
ENG implant, Nexplanon, oral ulipristal acetate, Ella
University of Utah, Merck Sharp & Dohme LLC
Contraception
10/22
01/24
Premium, NCT02748460: Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

Active, not recruiting
N/A
1500
Europe, RoW
PregLem SA
Uterine Fibroids
12/22
12/22
NCT05285605: Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy

Completed
N/A
75
US
Ulipristal Acetate, Ella
Northwestern University, Society of Family Planning
Contraception, Contraceptive Usage, Reproductive Issues
03/23
01/24
NCT04028986: Esmya Versus Surgery Before IVF/ICSI

Active, not recruiting
N/A
40
Europe
Ulipristal Acetate 5 MG Oral Tablet, surgery for fibroid
Universitair Ziekenhuis Brussel
Fibroid; Uterus Tumor, Complicating Pregnancy, Infertility, Female, Surgical Procedure, Unspecified
12/25
06/26
Terrosa (teriparatide biosimilar) / Mochida, Gedeon Richter
2018-003888-56: Diagnosis and treatment of bone disease in patients with chronic kidney disease

Not yet recruiting
4
66
Europe
Solution for injection, Terrosa 20 micrograms/80 microliters solution for injection
Department of Nephrology, Herlev & Gentofte Hospital, Herlev Hospital, Augustinusfonden, Helen & Ejnar Bjoernows Fond, Danish Society of Nephrology, Herlev & Gentofte Hospital
Bone disease with low activity of the boneforming cells, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
DANDYNAMIC BONE, NCT04522622: Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

Recruiting
4
48
Europe
Teriparatide, Terrosa, DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT, Bone biopsy, Cardiac tests, Blood and urine samples and physical examination
Ditte Hansen, Odense University Hospital, Steno Diabetes Center Copenhagen, Rigshospitalet, Denmark, Aalborg University Hospital
Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease, Chronic Kidney Disease-Mineral and Bone Disorder
09/26
09/27
2018-002130-20: Study of Teriparatide in Stress Fracture Healing: RETURN

Not yet recruiting
3
136
Europe
Terrosa, FORSTEO, Suspension for injection in cartridge, Solution for injection in pre-filled pen, Terrosa, FORSTEO
Norfolk and Norwich University Hospitals NHS Foundation Trust
Healthy individuals with stress fractures., Healthy individuals with stress fractures., Body processes [G] - Bones and nerves physological processes [G11]
 
 
Bemfola (follitropin alfa biosimilar) / Gedeon Richter
2012-003412-31: Fertility preservation in breast cancer patients: oocytes or embryos vitrification. Préservation de la fertilité chez les patientes atteintes de cancer du sein : vitrification des ovocytes ou des embryons.

Ongoing
4
54
Europe
Letrozole, hormone folliculo–stimulante humaine recombinante, cetrorelix acetate, menotrophine, follitropine alfa, Film-coated tablet, Solution for injection in pre-filled pen, Powder and solvent for solution for injection, Concentrate and solvent for suspension for injection, Femara, Gonal-f 300IU, Gonal-f 900IU, Cétrotide, Menopur 75IU, Decapeptyl 0,1mg, Bemfola 150UI/0,25 ml, Bemfola 225 UI/0,375ml, Bemfola 300 UI/0,375ml
CUB - Hôpital Erasme, CUB - Hôpital Erasme
The aim of this trial is to offer a safe and efficient alternative protocol to preserve fertility by storing oocytes in breast cancer patients before chemotherapy. Letrozole, an inhibitor of aromatase, is administered during standard gonadotropins ovarian stimulation to maintain a low estradiol level during ovarian stimulation in patients with hormono-sensitive tumour., Letrozole is associated with standard ovarian stimulation in order preserve fertility by storing oocytes/embryos in breast cancer patients before chemotherapy by maintaining low estradiol level., Diseases [C] - Cancer [C04]
 
 
2020-001218-39: Estradiol levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer (FET) cycle Østradiol-niveauer i tidlig graviditet efter naturlig, østradiol + progesteron eller gonadotropin-stimuleret frysecyklus.

Not yet recruiting
4
300
Europe
estradiol, bemfola, cyclogest, ovitrelle, 30158EU/1/00/165/007( marketing code), Tablet, Solution for injection/infusion, Vaginal tablet, Suspension for injection in pre-filled pen, Estradiol, bemfola, Cyclogest, ovitrelle
fertility clinic, Herlev university hospital, Fertilti clinic Hvidovre University hospital, Fertility clinic Herlev University Hospital, Fertility clinic Hvidovre University Hospital
Infertile women Infertile kvinder, Infertile women Ufrivilligt barnløse kvinder, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
NCT05103228: Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders

Completed
N/A
190
Europe
Follitropin Alfa, Ovaleap (Theramex Ireland Limited), Bemfola (Richter Gedeon Nyrt., Hungary), Gonal F (Merck Europe B.V.), Follitropin delta, Rekovelle (Ferring Pharmaceuticals A/S, Denmark), human menopausal gonadotropin, Menopur (Ferring Pharmaceuticals A/S, Denmark)
Peter Kovacs MD
Infertility, Ovarian Dysfunction
07/23
07/23
ACTRN12618000728235: A patient satisfaction evaluation study of Bemfola (recombinant FSH) administered with a 12mm needle or a 4mm needle in the treatment of subjects undergoing invitro fertilisation (IVF)

Recruiting
N/A
112
 
Dr Rachael Knight, Gedeon Richter Australia Pty Ltd
Reproductive Health and Childbirth, Invitro Fertilization, Infertility
 
 
Starjemza (ustekinumab-hmny) / Dr. Reddy’s, Bio-Thera Solutions, Pharmapark, Hikma, Biomm, Gedeon Richter, Astra Industrial Group
NCT04728360 / 2020-004504-33: Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

Completed
3
556
RoW
BAT2206, Stelara (EU-sourced)
Bio-Thera Solutions, Bio-Thera Solutions, Ltd.
Plaque Psoriasis
10/22
07/23
2020-004504-33: Study to Compare Efficacy and Safety of BAT2206 with Stelara® in Patients with Moderate to Severe Plaque Psoriasis

Not yet recruiting
3
556
Europe
Recombinant Human Anti-IL12 Monoclonal Antibody, BAT2206, Solution for injection in pre-filled syringe, Stelara®
Bio-Thera Solutions, Ltd., Bio-Thera Solutions, Ltd.
Moderate to Severe Plaque Psoriasis, chronic autoimmune disorder that causes the excessive buildup of skin cells, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
ChiCTR2000030273: A Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects

Not yet recruiting
1
270
 
BAT2206 injection, 45mg; Stelara (EU-licensed); 45mg; Stelara (US-licensed), 45mg
The First Hospital of Jinlin University; Bio-thera Solutions, Ltd., Self-finance
Psoriasis
 
 
RGB-14-P (denosumab biosimilar) / Gedeon Richter
NCT05087030 / 2020-006017-38: Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

Completed
3
473
Europe, US, RoW
RGB-14-P, Prolia®
Gedeon Richter Plc.
Postmenopausal Osteoporosis
10/23
11/23
LusiNEX (tocilizumab biosimilar) / Gedeon Richter, Mochida
ACTRN12618000859280: Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)

Active, not recruiting
1
190
 
Mycenax Biotech Inc., Mycenax Biotech Inc.
Elevated liver enzymes, neutropenia, thrombocytopenia
 
 

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