Theramex Trials - LARVOL Sigma

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Yselty (linzagolix) / Kissei, Syneos Health

NCT04335591 / 2019-002410-39: Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

Completed

356

Europe, US, RoW

75 mg linzagolix tablet, 200 mg linzagolix tablet, Placebo tablet to match 75 mg linzagolix tablet, Placebo tablet to match 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg), Placebo capsule to match Add-back capsule

Kissei Pharmaceutical Co., Ltd.

Endometriosis

09/22

12/22

NCT05620355: Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.

Recruiting

312

RoW

BG2109, Placebo for BG2109, Placebo for add-back therapy, Add-back therapy

Bio Genuine (Shanghai) Biotech Co., Ltd.

Uterine Fibroids, Heavy Menstrual Bleeding

05/24

03/25

NCT05894135: Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

Recruiting

540

RoW

BG2109 100mg, BG2109 200mg, ABT(E2 1 mg / NETA 0.5 mg), BG2109 100mg Placebo, BG2109 200mg Placebo, ABT Placebo

Bio Genuine (Shanghai) Biotech Co., Ltd.

Endometriosis, Moderate to Severe Endometriosis-associated Pain

06/24

03/25

NCT05445167: A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

Completed

Japan

KLH-2109, Placebo

Kissei Pharmaceutical Co., Ltd.

Uterine Fibroids (MeSH Heading: Leiomyoma)

02/24

NCT05440383: A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Completed

287

Japan

KLH-2109, Leuprorelin

Kissei Pharmaceutical Co., Ltd.

Uterine Fibroids (MeSH Heading: Leiomyoma)

08/24

NCT07015268: A Clinical Study of KLH-2109 in Patients With Endometriosis

Recruiting

288

Japan

KLH-2109, Leuprorelin acetate

Kissei Pharmaceutical Co., Ltd.

Endometriosis

11/27

Uterine Leiomyoma-1: Phase II trial of KLH-2109

Ongoing

RoW

KLH-2109

KISSEI

Uterine Leiomyoma

2017-004043-21: A pilot study to assess the efficacy and safety of OBE2109 in subjects with rectovaginal endometriosis.

Terminated

Europe

OBE2109, OBE2109, Film-coated tablet

ObsEva SA, ObsEva SA

Rectovaginal endometriosis, Rectovaginal endometriosis, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

NCT05738382: Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures

Not yet recruiting

240

RoW

BG2109, Cetrorelix, Cetrorelix Acetate

Bio Genuine (Shanghai) Biotech Co., Ltd.

Assisted Reproductive Technology, Controlled Ovarian Hyperstimulation

06/24

12/24

Femseven (estradiol transdermal) / Theramex, EMD Serono

PATCH, NCT00303784 / 2005-001030-33: Prostate Adenocarcinoma TransCutaneous Hormones

Recruiting

2200

Europe

Goserelin, Zoladex, Estradiol, FemSeven

University College, London, Medical Research Council

Anemia, Cardiovascular Complications, Hot Flashes, Osteoporosis, Prostate Cancer

08/21

2004-000193-31: STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

Not yet recruiting

2/3

12000

Europe

Zometa, Taxotere, Celebrex, Zytiga, Xtandi, Metformin, Progynova, FemSeven, Docetaxel, Hormone Therapy, Firmagon, Erleada, Concentrate for solution for infusion, Concentrate for suspension for injection, Capsule, hard, Film-coated tablet, Capsule, soft, Transdermal patch, Injection, Powder and solvent for solution for injection, Tablet, Zometa, Taxotere, Celebrex, Zytiga, Xtandi, Metformin, Progynova, FemSeven, Docetaxel, Hormone Therapy, Firmagon, Erleada

University College London, Cancer Research United Kingdom (CRUK), Astellas, Clovis Oncology, Janssen Pharmaceutica, Novartis Pharmaceutical, Sanofi-Aventis, Pfizer

Prostate Cancer, Prostate Cancer, Diseases [C] - Cancer [C04]

2004-002677-24: Hormonersättningseffekt på serotoninåterupptag hos ooforektomerade kvinnor

Ongoing

Europe

FemSeven, Undestor, FemSeven, Undestor, FemSeven

Karolinska Institutet, Institutionen för klinisik neurovetenskap, sektion för psykiatri

Bilateral oophorectomy and hysterectomy and a wish for hormonal replacement therapy afterwards.

Denub (denosumab biosimilar) / Alkem Labs, Theramex

NCT05405725: A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

Recruiting

504

RoW

ENZ215, Prolia

Enzene Biosciences Ltd., Alkem Laboratories Ltd

Postmenopausal Osteoporosis

02/24

08/24

2021-004811-26: A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with Osteoporosis

Completed

504

Europe, RoW

Enzene Denosumab (ENZ215), EU licensed Prolia®, ENZ215, Solution for injection in pre-filled syringe, Prolia

Alkem Laboratories Limited, Enzene BioSciences Ltd.,

Postmenopausal osteoporosis, Osteoporosis in women after menopause, Body processes [G] - Bones and nerves physological processes [G11]

NCT05245669: Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

Recruiting

207

Europe

ENZ215, EU Sourced Prolia, US Sourced Prolia

Enzene Biosciences Ltd., Alkem Laboratories Ltd

Healthy Male Subjects

05/24

tocilizumab biosimilar / Alkem Labs, Theramex

No trials found

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Yselty (linzagolix) / Kissei, Syneos Health

NCT04335591 / 2019-002410-39: Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

Completed

356

Europe, US, RoW

Kissei Pharmaceutical Co., Ltd.

Endometriosis

09/22

12/22

NCT05620355: Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.

Recruiting

312

RoW

BG2109, Placebo for BG2109, Placebo for add-back therapy, Add-back therapy

Bio Genuine (Shanghai) Biotech Co., Ltd.

Uterine Fibroids, Heavy Menstrual Bleeding

05/24

03/25

NCT05894135: Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

Recruiting

540

RoW

BG2109 100mg, BG2109 200mg, ABT(E2 1 mg / NETA 0.5 mg), BG2109 100mg Placebo, BG2109 200mg Placebo, ABT Placebo

Bio Genuine (Shanghai) Biotech Co., Ltd.

Endometriosis, Moderate to Severe Endometriosis-associated Pain

06/24

03/25

NCT05445167: A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

Completed

Japan

KLH-2109, Placebo

Kissei Pharmaceutical Co., Ltd.

Uterine Fibroids (MeSH Heading: Leiomyoma)

02/24

NCT05440383: A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Completed

287

Japan

KLH-2109, Leuprorelin

Kissei Pharmaceutical Co., Ltd.

Uterine Fibroids (MeSH Heading: Leiomyoma)

08/24

NCT07015268: A Clinical Study of KLH-2109 in Patients With Endometriosis

Recruiting

288

Japan

KLH-2109, Leuprorelin acetate

Kissei Pharmaceutical Co., Ltd.

Endometriosis

11/27

Uterine Leiomyoma-1: Phase II trial of KLH-2109

Ongoing

RoW

KLH-2109

KISSEI

Uterine Leiomyoma

2017-004043-21: A pilot study to assess the efficacy and safety of OBE2109 in subjects with rectovaginal endometriosis.

Terminated

Europe

OBE2109, OBE2109, Film-coated tablet

ObsEva SA, ObsEva SA

Rectovaginal endometriosis, Rectovaginal endometriosis, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

NCT05738382: Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures

Not yet recruiting

240

RoW

BG2109, Cetrorelix, Cetrorelix Acetate

Bio Genuine (Shanghai) Biotech Co., Ltd.

Assisted Reproductive Technology, Controlled Ovarian Hyperstimulation

06/24

12/24

Femseven (estradiol transdermal) / Theramex, EMD Serono

PATCH, NCT00303784 / 2005-001030-33: Prostate Adenocarcinoma TransCutaneous Hormones

Recruiting

2200

Europe

Goserelin, Zoladex, Estradiol, FemSeven

University College, London, Medical Research Council

Anemia, Cardiovascular Complications, Hot Flashes, Osteoporosis, Prostate Cancer

08/21

2004-000193-31: STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

Not yet recruiting

2/3

12000

Europe

University College London, Cancer Research United Kingdom (CRUK), Astellas, Clovis Oncology, Janssen Pharmaceutica, Novartis Pharmaceutical, Sanofi-Aventis, Pfizer

Prostate Cancer, Prostate Cancer, Diseases [C] - Cancer [C04]

2004-002677-24: Hormonersättningseffekt på serotoninåterupptag hos ooforektomerade kvinnor

Ongoing

Europe

FemSeven, Undestor, FemSeven, Undestor, FemSeven

Karolinska Institutet, Institutionen för klinisik neurovetenskap, sektion för psykiatri

Bilateral oophorectomy and hysterectomy and a wish for hormonal replacement therapy afterwards.

Denub (denosumab biosimilar) / Alkem Labs, Theramex

NCT05405725: A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

Recruiting

504

RoW

ENZ215, Prolia

Enzene Biosciences Ltd., Alkem Laboratories Ltd

Postmenopausal Osteoporosis

02/24

08/24

2021-004811-26: A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with Osteoporosis

Completed

504

Europe, RoW

Enzene Denosumab (ENZ215), EU licensed Prolia®, ENZ215, Solution for injection in pre-filled syringe, Prolia

Alkem Laboratories Limited, Enzene BioSciences Ltd.,

Postmenopausal osteoporosis, Osteoporosis in women after menopause, Body processes [G] - Bones and nerves physological processes [G11]

NCT05245669: Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

Recruiting

207

Europe

ENZ215, EU Sourced Prolia, US Sourced Prolia

Enzene Biosciences Ltd., Alkem Laboratories Ltd

Healthy Male Subjects

05/24

tocilizumab biosimilar / Alkem Labs, Theramex

No trials found



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