{"id":"estrace-0-01-vaginal-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 potent estrogen that binds to estrogen receptors in vaginal epithelial cells, promoting cell proliferation, increasing vaginal blood flow, and restoring normal vaginal pH and lubrication. This local hormone replacement therapy alleviates symptoms such as vaginal dryness, itching, burning, and dyspareunia associated with menopause or estrogen deficiency.","oneSentence":"Estrace vaginal cream delivers estradiol directly to vaginal tissues to restore estrogen levels and relieve symptoms of vaginal atrophy and menopausal urogenital changes.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:29:42.805Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Vaginal atrophy and urogenital symptoms associated with menopause"},{"name":"Atrophic vaginitis"}]},"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":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Estrace 0.01% Vaginal Cream","genericName":"Estrace 0.01% Vaginal Cream","companyName":"University of California, Irvine","companyId":"university-of-california-irvine","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Estrace vaginal cream delivers estradiol directly to vaginal tissues to restore estrogen levels and relieve symptoms of vaginal atrophy and menopausal urogenital changes. Used for Vaginal atrophy and urogenital symptoms associated with menopause, Atrophic vaginitis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}