{"id":"leuprolide-depot","safety":{"commonSideEffects":[{"rate":"60-80","effect":"Hot flashes"},{"rate":"5-15","effect":"Injection site reaction"},{"rate":"40-60","effect":"Decreased libido"},{"rate":"30-50","effect":"Erectile dysfunction"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Fatigue"},{"rate":null,"effect":"Bone density loss (with prolonged use)"},{"rate":"variable","effect":"Transient testosterone surge (flare)"}]},"_chembl":{"chemblId":"CHEMBL1200775","moleculeType":"Protein","molecularWeight":"1269.47"},"_dailymed":{"setId":"1563a30b-66e0-445d-ba3e-1ccd5218133f","title":"LEUPROLIDE ACETATE DEPOT (LEUPROLIDE ACETATE) KIT [CIPLA USA INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Leuprolide binds to GnRH receptors in the pituitary gland, initially causing a surge in LH and FSH (flare effect), followed by sustained suppression of these hormones through receptor desensitization. This results in castration-level testosterone suppression in males and estrogen suppression in females, making it effective for hormone-dependent conditions. The depot formulation provides sustained drug release over weeks to months.","oneSentence":"Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T04:03:23.159Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced prostate cancer"},{"name":"Endometriosis"},{"name":"Uterine fibroids (leiomyomata)"},{"name":"Precocious puberty"},{"name":"Breast cancer (premenopausal women)"}]},"trialDetails":[{"nctId":"NCT04484818","phase":"PHASE3","title":"Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2021-03-01","conditions":"Prostate Carcinoma","enrollment":27},{"nctId":"NCT06169124","phase":"PHASE2","title":"Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-02-08","conditions":"Adult Ovarian Granulosa Cell Tumor","enrollment":37},{"nctId":"NCT06654336","phase":"PHASE2","title":"Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)","status":"RECRUITING","sponsor":"Ontario Clinical Oncology Group (OCOG)","startDate":"2026-03-30","conditions":"Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer","enrollment":162},{"nctId":"NCT04557059","phase":"PHASE3","title":"A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"2020-11-12","conditions":"Prostatic Neoplasms","enrollment":693},{"nctId":"NCT07142551","phase":"PHASE2","title":"Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response","status":"RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2026-03-09","conditions":"Metastatic Castration-resistant Prostate Cancer","enrollment":60},{"nctId":"NCT07455903","phase":"PHASE2","title":"Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT","status":"NOT_YET_RECRUITING","sponsor":"Baptist Health South Florida","startDate":"2026-04","conditions":"Prostate Cancer, Localized Prostate Carcinoma","enrollment":50},{"nctId":"NCT05827081","phase":"PHASE3","title":"Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-02-28","conditions":"Early Breast Cancer","enrollment":1400},{"nctId":"NCT04423211","phase":"PHASE3","title":"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","status":"RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2020-10-08","conditions":"Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma","enrollment":804},{"nctId":"NCT05617885","phase":"PHASE1","title":"Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Praful Ravi, MB BCHir, MRCP","startDate":"2023-08-09","conditions":"Metastatic Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Cancer","enrollment":9},{"nctId":"NCT01786265","phase":"PHASE2","title":"Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2013-02-05","conditions":"Prostate Adenocarcinoma, Recurrent Prostate Carcinoma","enrollment":310},{"nctId":"NCT06305598","phase":"PHASE1","title":"Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer","status":"RECRUITING","sponsor":"Roswell Park Cancer Institute","startDate":"2024-12-19","conditions":"Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8","enrollment":14},{"nctId":"NCT02274779","phase":"PHASE2","title":"Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer","status":"COMPLETED","sponsor":"Institut Cancerologie de l'Ouest","startDate":"2014-08-20","conditions":"Prostate Cancer","enrollment":74},{"nctId":"NCT06627530","phase":"PHASE4","title":"COACTION Trial - 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