- |||||||||| leuprolide acetate for depot suspension / Generic mfg., estradiol/norethindrone oral / Generic mfg.
Clinical, Journal: Apoplectic leiomyomas: does ethnicity make a difference? a clinicopathologic study. (Pubmed Central) - Apr 12, 2022 Apoplectic leiomyomas were observed in 22.1% (77/349) of women ≤ 45 years of age compared to 11.3% (59/520) of women > 45 years of age (p < 0.0001), and this difference remained statistically significant regardless of hormone use.This is the largest study to date examining apoplectic leiomyomas in women on known hormonal therapy compared to women with uterine leiomyomas, but not on hormonal therapy. Information about hormonal therapy, ethnicity, and age can be helpful in the diagnostic interpretation of apoplectic leiomyoma.
- |||||||||| Xtandi (enzalutamide) / Pfizer, Astellas, Erleada (apalutamide) / J&J
Trial completion date, Trial primary completion date: Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov) - Apr 11, 2022 P=N/A, N=60, Active, not recruiting, Switching from GnRH antagonist to a long-acting LH-RH agonist appears to be a reasonable option that does not diminish efficacy or exacerbate adverse events. Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024
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Biomarker, Enrollment closed, Trial completion date, Trial primary completion date: Menopausal Sleep Fragmentation and Body Fat Gain (clinicaltrials.gov) - Apr 11, 2022 P4, N=58, Active, not recruiting, Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024 Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Dec 2021 --> Jul 2022
- |||||||||| Nubeqa (darolutamide) / Bayer, Orion Corp, Erleada (apalutamide) / J&J, Firmagon (degarelix) / Astellas, Ferring
Comparative out-of-pocket costs of treatment options in privately insured patients with advanced prostate cancer (Room 222) - Apr 10, 2022 - Abstract #AUA2022AUA_2028; Conclusions : Patients receiving novel hormonal agents had substantially higher OOPC than other therapies. In addition to raising awareness among prescribers, these data support the inclusion of financial toxicity discussions as a part of patient counseling for these agents.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Clinical, Review, Journal: A case report of precocious puberty related to Rett syndrome and a literature review. (Pubmed Central) - Apr 9, 2022 PP was controlled after treatment with leuprorelin 3.75 mg for one year. In addition, the genetic and phenotypic spectrum of previously reported cases of Rett syndrome with precocious puberty are reviewed and summarized.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Journal: Lipid-Based Ionic-Liquid-Mediated Nanodispersions as Biocompatible Carriers for the Enhanced Transdermal Delivery of a Peptide Drug. (Pubmed Central) - Apr 9, 2022 In this study, we report the formulation of a peptide-LBIL complex microencapsulated in an oil phase as a potential carrier for the transdermal delivery of leuprolide acetate as a model hydrophilic peptide...In vitro and in vivo cytotoxicity studies of the IL/O-NDs revealed the biocompatibility of the LBIL-based formulations. These results indicated that IL/O-NDs are promising biocompatible carriers for lipid-peptide TDDSs.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: PRIME-CUT: REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) - Apr 4, 2022 P2, N=20, Recruiting, Lack of conclusive comparative evidence makes it imperative to have a holistic approach of considering the patient profile and the disease characteristics to select the appropriate GnRH-A for ADT in prostate cancer. Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Sep 2020 --> Dec 2022
- |||||||||| Herceptin (trastuzumab) / Roche
Journal: Poorly Differentiated Scrotal Carcinoma With Apocrine Immunophenotype. (Pubmed Central) - Mar 23, 2022 Molecular analysis (n = 2) detected a HER-2 mutation in one and microsatellite instability in another. Although the presence of an intraepidermal pagetoid component could hint toward the diagnosis of invasive extramammary Paget disease, tumors without an intraepidermal component could be diagnostically challenging given the lack of morphologic evidence of apocrine differentiation.
- |||||||||| Xeljanz (tofacitinib) / Pfizer, Humira (adalimumab) / Eisai, AbbVie
Recalcitrant Pediatric Bullous Erythema Multiforme Responsive to Oral Tofacitinib (Poster Presentation Center 1) - Mar 21, 2022 - Abstract #AAD2022AAD_2427; Adjunctive therapies including acyclovir and leuprolide had also proven ineffective.Physical examination revealed well-defined, targetoid macules with central vesiculation scattered upon all four extremities...Scattered, erythematous erosions were seen on the hard palate and buccal mucosa; in addition, the lips featured hemorrhagic crusts.Biopsies: Punch biopsies of lesions obtained from the left arm revealed a brisk lymphocytic infiltrate at the dermoepidermal junction with necrotic keratinocytes observed at all levels of the epidermis.Laboratory Data: Further work-up revealed negative PCR for EBV & CMV, negative ANA, negative HIV, negative Mycoplasma antibodies, and negative HSV-2 & HSV-2 antibodies.Diagnosis: Bullous erythema multiforme.Clinical Course and Treatment: Patient was transitioned to oral tofacitinib 5 mg twice daily with corresponding complete resolution of active lesions. Disease activity has remained quiescent for over two years, which represents the longest period of time without a disease flare since the patient’s initial diagnosis during childhood.
- |||||||||| leuprorelin depot / Generic mfg., tamoxifen / Generic mfg.
Clinical, Journal: Role of leuprorelin on ovarian function of patients with receptor-positive premenopausal breast cancer. (Pubmed Central) - Mar 16, 2022 The quality of life score and activity of life score in the observation group were higher. Leuprorelin combined with endocrine drugs can obviously protect ovarian function with significant long-term effect, which effectively reduces the impact of adverse reactions on receptor-positive PBC patients, with higher safety and better feasibility.
- |||||||||| Xtandi (enzalutamide) / Pfizer, Astellas, Erleada (apalutamide) / J&J, Firmagon (degarelix) / Astellas, Ferring
Trial initiation date: OMPCa-ENSURE: Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer (clinicaltrials.gov) - Mar 16, 2022 P2, N=160, Recruiting, Leuprorelin combined with endocrine drugs can obviously protect ovarian function with significant long-term effect, which effectively reduces the impact of adverse reactions on receptor-positive PBC patients, with higher safety and better feasibility. Initiation date: Jan 2022 --> Apr 2022
- |||||||||| leuprorelin depot / Generic mfg.
Clinical, Journal: Effects of Gonadotropin-Releasing Hormone Analogs on Ovarian Function Against Chemotherapy-Induced Gonadotoxic Effects in Premenopausal Women With Breast Cancer in China: A Randomized Clinical Trial. (Pubmed Central) - Mar 15, 2022 P3 This randomized clinical trial, conducted at the Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital and Zhejiang Cancer Hospital in China, was an open-label trial involving premenopausal women aged 18 to 49 years with operable stage I to III breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned in 2 parallel groups: treatment with chemotherapy with or without GnRHa...In patients randomized to receive GnRHa, 3.6 mg of goserelin or 3.75 mg of leuprorelin was injected subcutaneously once every 28 days from 1 to 2 weeks before the first cycle of chemotherapy to 4 weeks after the last cycle of chemotherapy...This randomized clinical trial found that administering GnRHa in treatment with chemotherapy for premenopausal patients with breast cancer reduces the risk of POI, which promotes the recovery of ovarian function. ClinicalTrials.gov Identifier: NCT02518191.
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Late onset of pituitary apoplexy following gonadotropin-releasing hormone agonist for prostate cancer treatment. (Pubmed Central) - Mar 15, 2022 We present a case of a man in his late 50s who developed PA following treatment of PCa with leuprolide...Anterior pituitary hormone workup along with pituitary MRI confirmed the diagnosis of PA and patient was subsequently treated with adequate replacement of pituitary hormone with significant improvement in his symptoms. It is very important to keep a high index of suspicion for PA, especially among elderly patients receiving GnRH agonist treatment for PCa.
- |||||||||| Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Clinical, P3 data, Journal, Head-to-Head: Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study. (Pubmed Central) - Mar 9, 2022 P3 Relugolix was noninferior to LEU for treating endometriosis-associated pelvic pain. Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.
- |||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Cost-Effectiveness Analysis of Androgen Deprivation Therapy with Relugolix for the Treatment of Advanced Prostate Cancer (Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_1659; Though the influence of adverse events was not considered in the analysis, ADT with relugolix was not a cost-effective choice for the treatment of APC when compared to ADT with leuprolide. While the analysis revealed that patients had a slight chance of sustaining testosterone suppression with relugolix in terms of PFS, ADT with relugolix provided no overall survival advantages over ADT with leuprolide.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., docetaxel / Generic mfg.
Trial completion: A Registry for Patients Treated on the Clinical Trial TAX 3503 (clinicaltrials.gov) - Mar 8, 2022 P3, N=52, Completed, While the analysis revealed that patients had a slight chance of sustaining testosterone suppression with relugolix in terms of PFS, ADT with relugolix provided no overall survival advantages over ADT with leuprolide. Active, not recruiting --> Completed
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Aggressive (deep) angiomyxoma of the vulva: a case report. (Pubmed Central) - Feb 25, 2022 Aggressive angiomyxoma is one of the differential diagnoses for vulvovaginal growth in a female. As the tumor is well known for local recurrences, correct diagnosis and appropriate management using a multidisciplinary approach are crucial to managing such patients.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Phase classification: The Effects of Reproductive Hormones on Mood and Behavior (clinicaltrials.gov) - Feb 24, 2022 P1/2, N=100, Completed, In conclusion, our study demonstrated that LA-CPSC injectable bone cement should be a viable solution to repair bone fractures under the osteoporotic conditions. Phase classification: P=N/A --> P1/2
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