{"id":"estrace-0-01-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Vaginal irritation or burning"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Vaginal bleeding or spotting"}]},"_chembl":{"chemblId":"CHEMBL2108947","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Estradiol is a potent estrogen that binds to estrogen receptors in vaginal epithelial cells, restoring tissue thickness, elasticity, and moisture. This localized hormone replacement therapy alleviates vaginal dryness, irritation, and dyspareunia associated with menopause or other causes of estrogen deficiency. The 0.01% cream formulation provides topical delivery with minimal systemic absorption.","oneSentence":"Estrace cream delivers estradiol, a natural estrogen, directly to vaginal and vulvar tissues to relieve symptoms of atrophic vaginitis and urogenital atrophy.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:36.866Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atrophic vaginitis (vaginal atrophy) associated with menopause"},{"name":"Urogenital atrophy symptoms including vaginal dryness and dyspareunia"}]},"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":"NCT02195986","phase":"PHASE3","title":"A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2014-06","conditions":"Atrophic Vaginitis","enrollment":366},{"nctId":"NCT02995694","phase":"PHASE3","title":"A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis","status":"COMPLETED","sponsor":"Alvogen Pine Brook LLC","startDate":"2016-03","conditions":"Atrophic Vaginitis","enrollment":535},{"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":17,"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® 0.01% cream","genericName":"Estrace® 0.01% cream","companyName":"Mylan Pharmaceuticals Inc","companyId":"mylan-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Estrace cream delivers estradiol, a natural estrogen, directly to vaginal and vulvar tissues to relieve symptoms of atrophic vaginitis and urogenital atrophy. Used for Atrophic vaginitis (vaginal atrophy) associated with menopause, Urogenital atrophy symptoms including vaginal dryness and dyspareunia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}