{"id":"ospemifene-dose-1","safety":{"commonSideEffects":[{"rate":"~4-6%","effect":"Hot flashes"},{"rate":"~2-4%","effect":"Vaginal discharge"},{"rate":"~1-2%","effect":"Vaginal bleeding or spotting"},{"rate":"~2-3%","effect":"Headache"},{"rate":"~1-2%","effect":"Muscle spasms"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Ospemifene selectively binds to estrogen receptors in the vaginal epithelium, promoting tissue proliferation and improving vaginal maturation and lubrication. This mechanism addresses the vaginal atrophy and dryness characteristic of genitourinary syndrome of menopause (GSM), thereby reducing pain during intercourse without systemic hormonal effects typical of hormone replacement therapy.","oneSentence":"Ospemifene is a selective estrogen receptor modulator (SERM) that acts as an estrogen agonist in vaginal tissue to treat moderate to severe dyspareunia caused by genitourinary syndrome of menopause.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:25:00.172Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe dyspareunia due to genitourinary syndrome of menopause (GSM)"}]},"trialDetails":[{"nctId":"NCT01585558","phase":"PHASE3","title":"Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus","status":"COMPLETED","sponsor":"Shionogi","startDate":"2006-05-16","conditions":"Atrophy, Vaginal Diseases","enrollment":180},{"nctId":"NCT01586364","phase":"PHASE3","title":"Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus","status":"COMPLETED","sponsor":"Shionogi","startDate":"2006-05-08","conditions":"Atrophy, Vaginal Diseases","enrollment":301},{"nctId":"NCT00729469","phase":"PHASE3","title":"Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity","status":"COMPLETED","sponsor":"Shionogi","startDate":"2008-07","conditions":"Atrophy, Vaginal Diseases","enrollment":919},{"nctId":"NCT00566982","phase":"PHASE3","title":"A Clinical Study to Evaluate the Safety of Ospemifene","status":"COMPLETED","sponsor":"Shionogi","startDate":"2007-10","conditions":"Atrophy, Vaginal Diseases","enrollment":426},{"nctId":"NCT00630539","phase":"PHASE2","title":"A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women","status":"COMPLETED","sponsor":"Shionogi","startDate":"2007-08","conditions":"Atrophy, Vaginal Diseases","enrollment":126},{"nctId":"NCT00276094","phase":"PHASE3","title":"A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women","status":"COMPLETED","sponsor":"Shionogi","startDate":"2006-01","conditions":"Atrophy, Vaginal Diseases","enrollment":826}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"Ospemifene (Dose 1)","genericName":"Ospemifene (Dose 1)","companyName":"Shionogi","companyId":"shionogi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ospemifene is a small molecule that modulates the estrogen receptor, classified as a modulator. It is being studied for the treatment of vulvar and vaginal atrophy in postmenopausal women, with a dose of 60 mg being evaluated in clinical trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}