{"id":"leuprolide-acetate-in-depot-suspension","safety":{"commonSideEffects":[{"rate":"60-80","effect":"Hot flashes"},{"rate":"10-20","effect":"Headache"},{"rate":"10-15","effect":"Mood changes / depression"},{"rate":"10-20","effect":"Vaginal dryness"},{"rate":"5-10","effect":"Injection site reactions"},{"rate":"10-15","effect":"Decreased libido"},{"rate":null,"effect":"Bone density loss (with prolonged use)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Leuprolide works by binding 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 profound suppression of testosterone in males and estrogen in females. The depot suspension formulation provides sustained release over weeks to months, maintaining therapeutic hormone suppression.","oneSentence":"Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:33:55.656Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Endometriosis"},{"name":"Uterine fibroids (leiomyomas)"},{"name":"Assisted reproductive technology (ART) / in vitro fertilization (IVF) support"},{"name":"Precocious puberty"}]},"trialDetails":[{"nctId":"NCT03649724","phase":"PHASE2","title":"The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's","status":"ACTIVE_NOT_RECRUITING","sponsor":"Weill Medical College of Cornell University","startDate":"2020-11-27","conditions":"Alzheimer Disease, Mild Cognitive Impairment","enrollment":180},{"nctId":"NCT06926933","phase":"PHASE4","title":"Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty","status":"RECRUITING","sponsor":"HanAll BioPharma Co., Ltd.","startDate":"2024-12-12","conditions":"CPP","enrollment":50},{"nctId":"NCT00687739","phase":"PHASE3","title":"Prevention of Obesity in Women Via Estradiol Regulation","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2008-05","conditions":"Obesity","enrollment":79},{"nctId":"NCT01326312","phase":"PHASE2","title":"Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer","status":"TERMINATED","sponsor":"GTx","startDate":"2011-06","conditions":"Prostate Cancer","enrollment":159},{"nctId":"NCT03085095","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-04-18","conditions":"Prostate Cancer","enrollment":1134},{"nctId":"NCT02122198","phase":"NA","title":"Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2014-09-08","conditions":"Cognitive Impairment, Executive Dysfunction, Endothelial Dysfunction","enrollment":17},{"nctId":"NCT00621179","phase":"PHASE4","title":"Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF","status":"COMPLETED","sponsor":"Colorado Center for Reproductive Medicine","startDate":"2003-03","conditions":"Endometriosis, Infertility","enrollment":37},{"nctId":"NCT03261999","phase":"PHASE3","title":"Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer","status":"COMPLETED","sponsor":"Foresee Pharmaceuticals Co., Ltd.","startDate":"2017-09-26","conditions":"Prostatic Neoplasms","enrollment":144},{"nctId":"NCT01712230","phase":"NA","title":"Females, Aging, Metabolism, and Exercise","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2012-10","conditions":"Obesity","enrollment":47},{"nctId":"NCT02234115","phase":"PHASE3","title":"Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma","status":"COMPLETED","sponsor":"Foresee Pharmaceuticals Co., Ltd.","startDate":"2014-08","conditions":"Prostatic Neoplasms","enrollment":137},{"nctId":"NCT01546454","phase":"NA","title":"Relationship Between the Menstrual Cycle and Heart Disease in Women","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2012-02","conditions":"Coronary Heart Disease","enrollment":5},{"nctId":"NCT02749825","phase":"PHASE4","title":"Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer","status":"TERMINATED","sponsor":"Pharmatech","startDate":"2002-09","conditions":"Prostate Cancer","enrollment":41},{"nctId":"NCT01069094","phase":"PHASE1, PHASE2","title":"A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata","status":"COMPLETED","sponsor":"Repros Therapeutics Inc.","startDate":"2004-07","conditions":"Uterine Leiomyomata","enrollment":29},{"nctId":"NCT00667446","phase":"PHASE3","title":"Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2008-12","conditions":"Precocious, Leuprolide Acetate, Luteinizing Hormone (LH)","enrollment":72},{"nctId":"NCT00635817","phase":"PHASE3","title":"A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty","status":"COMPLETED","sponsor":"Abbott","startDate":"2008-06","conditions":"Puberty, Precocious","enrollment":84}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Depot Lupron"],"phase":"marketed","status":"active","brandName":"Leuprolide acetate in depot suspension","genericName":"Leuprolide acetate in depot suspension","companyName":"Colorado Center for Reproductive Medicine","companyId":"colorado-center-for-reproductive-medicine","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production. Used for Endometriosis, Uterine fibroids (leiomyomata), Precocious puberty.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}