{"id":"generic-estradiol-vaginal-cream-usp-0-01","safety":{"commonSideEffects":[{"rate":null,"effect":"Vaginal irritation or burning"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Vaginal discharge"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Estradiol is a naturally occurring estrogen that acts as an agonist at estrogen receptors (ERα and ERβ) in the vaginal epithelium and urogenital tissues. Local vaginal application delivers high concentrations of estradiol directly to affected tissues while minimizing systemic absorption, restoring vaginal maturation, elasticity, and moisture to relieve symptoms of genitourinary syndrome of menopause (GSM).","oneSentence":"Estradiol binds to estrogen receptors in vaginal tissue to restore local estrogen levels and alleviate symptoms of vaginal atrophy and urogenital dysfunction.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:14:03.014Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atrophic vaginitis / Genitourinary syndrome of menopause (GSM)"},{"name":"Vaginal atrophy associated with menopause"}]},"trialDetails":[{"nctId":"NCT03294538","phase":"PHASE3","title":"Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2016-05-18","conditions":"Atrophic Vaginitis","enrollment":663}],"_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":"Generic Estradiol Vaginal Cream USP, 0.01%","genericName":"Generic Estradiol Vaginal Cream USP, 0.01%","companyName":"Actavis Inc.","companyId":"actavis-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Estradiol binds to estrogen receptors in vaginal tissue to restore local estrogen levels and alleviate symptoms of vaginal atrophy and urogenital dysfunction. Used for Atrophic vaginitis / Genitourinary syndrome of menopause (GSM), Vaginal atrophy associated with menopause.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}