{"id":"depot-leuprolide-norethindrone","safety":{"commonSideEffects":[{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Mood changes / depression"},{"rate":null,"effect":"Vaginal dryness"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Bone density loss"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Leuprolide is a GnRH agonist that initially stimulates then desensitizes GnRH receptors, leading to sustained suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby reducing ovarian estrogen and androgen production. Norethindrone, a synthetic progestin, is co-administered to prevent hypoestrogenic symptoms (hot flashes, bone loss) and maintain endometrial stability during prolonged GnRH agonist therapy.","oneSentence":"Leuprolide suppresses gonadotropin-releasing hormone (GnRH) signaling to reduce sex hormone production, while norethindrone provides progestin supplementation to prevent estrogen-induced side effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:09:03.117Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Endometriosis"},{"name":"Uterine fibroids (leiomyomata)"},{"name":"Central precocious puberty"}]},"trialDetails":[{"nctId":"NCT00229996","phase":"PHASE3","title":"Medical Treatment of Endometriosis-Associated Pelvic Pain","status":"COMPLETED","sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","startDate":"2004-07","conditions":"Endometriosis, Pelvic Pain","enrollment":194},{"nctId":"NCT00458458","phase":"PHASE3","title":"Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)","status":"UNKNOWN","sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","startDate":"2004-08","conditions":"Endometriosis, Dysmenorrhea, Dyspareunia","enrollment":112}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Depot-Leuprolide/Norethindrone","genericName":"Depot-Leuprolide/Norethindrone","companyName":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","companyId":"eunice-kennedy-shriver-national-institute-of-child-health-and-human-development","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Leuprolide suppresses gonadotropin-releasing hormone (GnRH) signaling to reduce sex hormone production, while norethindrone provides progestin supplementation to prevent estrogen-induced side effects. Used for Endometriosis, Uterine fibroids (leiomyomata), Central precocious puberty.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}