{"id":"relugolix-combination-therapy","safety":{"commonSideEffects":[{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased libido"},{"rate":null,"effect":"Erectile dysfunction"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL1800159","moleculeType":"Small molecule","molecularWeight":"623.64"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Relugolix combination therapy pairs the GnRH antagonist relugolix with estradiol and norethisterone acetate to provide androgen deprivation while mitigating hypogonadism-related side effects. By blocking GnRH signaling, it rapidly lowers sex hormone production, which is therapeutically beneficial in hormone-sensitive cancers. The addition of hormone replacement helps manage adverse effects associated with severe hormone suppression.","oneSentence":"Relugolix is a gonadotropin-releasing hormone (GnRH) antagonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to rapid reduction of testosterone and estrogen levels.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:31:44.551Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced prostate cancer requiring androgen deprivation therapy"},{"name":"Hormone receptor-positive breast cancer (in combination with other therapies)"}]},"trialDetails":[{"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":"NCT06330805","phase":"PHASE2","title":"Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer","status":"RECRUITING","sponsor":"Ohio State University Comprehensive Cancer Center","startDate":"2024-08-12","conditions":"Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8","enrollment":70},{"nctId":"NCT07440043","phase":"","title":"Relugolix for Endometriosis Associated Pain","status":"NOT_YET_RECRUITING","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2026-02-25","conditions":"Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome","enrollment":33},{"nctId":"NCT07100782","phase":"PHASE3","title":"Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain","status":"RECRUITING","sponsor":"University of Michigan","startDate":"2025-12-08","conditions":"Endometriosis, Pelvic Pain","enrollment":130},{"nctId":"NCT06631521","phase":"PHASE1","title":"Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer","status":"RECRUITING","sponsor":"AdventHealth","startDate":"2024-10-22","conditions":"Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery","enrollment":30},{"nctId":"NCT06059118","phase":"PHASE2","title":"Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer","status":"RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2023-10-04","conditions":"Prostate Cancer","enrollment":50},{"nctId":"NCT04513717","phase":"PHASE3","title":"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 PREDICT-RT Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"NRG Oncology","startDate":"2021-01-21","conditions":"Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8","enrollment":2753},{"nctId":"NCT04756037","phase":"PHASE3","title":"Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sumitomo Pharma Switzerland GmbH","startDate":"2021-03-18","conditions":"Contraception","enrollment":1020},{"nctId":"NCT07302451","phase":"PHASE2","title":"REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute, Naples","startDate":"2025-12-01","conditions":"Prostate Cancer (Adenocarcinoma)","enrollment":50},{"nctId":"NCT05189457","phase":"PHASE2","title":"First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"H. 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Used for Advanced prostate cancer requiring androgen deprivation therapy, Hormone receptor-positive breast cancer (in combination with other therapies).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}