{"id":"estradiol-0-01-vag-cream","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 bioidentical 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, thereby restoring vaginal moisture, elasticity, and pH balance without significant systemic hormonal effects.","oneSentence":"Estradiol binds to estrogen receptors in vaginal tissue to restore local estrogen levels and alleviate symptoms of vaginal atrophy and genitourinary syndrome of menopause.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:39:24.966Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Vaginal atrophy associated with menopause"},{"name":"Genitourinary syndrome of menopause (GSM)"}]},"trialDetails":[{"nctId":"NCT05672901","phase":"NA","title":"Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause","status":"RECRUITING","sponsor":"Stratpharma AG","startDate":"2023-04-04","conditions":"Genitourinary Syndrome of Menopause","enrollment":100},{"nctId":"NCT05317364","phase":"PHASE4","title":"Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery","status":"TERMINATED","sponsor":"University of Alabama at Birmingham","startDate":"2022-07-14","conditions":"Obstetric; Injury Pelvic Floor, Sexual Dysfunction, Anal Incontinence","enrollment":38},{"nctId":"NCT06353269","phase":"PHASE4","title":"Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of California, Irvine","startDate":"2024-06-14","conditions":"Recurrent Urinary Tract Infection, Hypoestrogenism","enrollment":111},{"nctId":"NCT07260825","phase":"PHASE2, PHASE3","title":"Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"TriHealth Inc.","startDate":"2025-12","conditions":"Vulvodynia, Dyspareunia, Lichen Sclerosus of Vulva","enrollment":44},{"nctId":"NCT02218463","phase":"NA","title":"Treatment of Prepubertal Labial Adhesions","status":"COMPLETED","sponsor":"Children's Mercy Hospital Kansas City","startDate":"2014-09","conditions":"Prepubertal Labial Adhesions","enrollment":43},{"nctId":"NCT05221021","phase":"PHASE4","title":"Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome","status":"RECRUITING","sponsor":"Walter Reed National Military Medical Center","startDate":"2022-10-01","conditions":"Overactive Bladder Syndrome","enrollment":152},{"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":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Estrace cream"],"phase":"marketed","status":"active","brandName":"Estradiol 0.01% Vag Cream","genericName":"Estradiol 0.01% Vag Cream","companyName":"TriHealth Inc.","companyId":"trihealth-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 genitourinary syndrome of menopause. Used for Vaginal atrophy associated with menopause, Genitourinary syndrome of menopause (GSM).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}