{"id":"estrace-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":{"chemblId":"CHEMBL2108947","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Estradiol is a bioidentical estrogen that binds to estrogen receptors in the vaginal epithelium, promoting cellular proliferation, increasing vaginal blood flow, and restoring vaginal moisture and elasticity. This local hormone replacement therapy alleviates symptoms such as vaginal dryness, dyspareunia, and urinary discomfort associated with menopause or estrogen deficiency.","oneSentence":"Estrace vaginal cream delivers estradiol directly to vaginal tissue to restore estrogen levels and relieve symptoms of vaginal atrophy and urogenital aging.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:35.476Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Vaginal atrophy and urogenital symptoms associated with menopause"},{"name":"Atrophic vaginitis"}]},"trialDetails":[{"nctId":"NCT03332303","phase":"PHASE3","title":"Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy","status":"COMPLETED","sponsor":"Prasco LLC","startDate":"2017-10-26","conditions":"Vulvar and Vaginal Atrophy","enrollment":540},{"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":2,"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":"Estrace® Vaginal Cream USP, 0.01%","genericName":"Estrace® Vaginal Cream USP, 0.01%","companyName":"Actavis Inc.","companyId":"actavis-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Estrace vaginal cream delivers estradiol directly to vaginal tissue to restore estrogen levels and relieve symptoms of vaginal atrophy and urogenital aging. Used for Vaginal atrophy and urogenital symptoms associated with menopause, Atrophic vaginitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}