{"id":"vaginal-estrogen","rwe":[{"pmid":"41701634","year":"2026","title":"Treatment of vulvovaginal atrophy is associated with high levels of satisfaction and improves symptom severity and patient-reported outcomes: 12-month results of the PatieEnt satisfactiON studY (PEONY).","journal":"Menopause (New York, N.Y.)"},{"pmid":"41598224","year":"2026","title":"Conservative Treatment in Stress Urinary Incontinence-Narrative Literature Review.","journal":"Life (Basel, Switzerland)"},{"pmid":"41496540","year":"2025","title":"Treatment patterns for genitourinary syndrome of menopause: a TriNetX analysis.","journal":"The Canadian journal of urology"},{"pmid":"41075854","year":"2026","title":"Prescribing Trends for Vaginal Estrogen: What Role Do Urogynecology and Reconstructive Pelvic Surgery Urologists Play?","journal":"Urology"},{"pmid":"39774067","year":"2025","title":"Energy-based interventions for genitourinary syndrome of menopause: a systematic review of randomized controlled trials and prospective observational studies.","journal":"Menopause (New York, N.Y.)"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00675688","NCT00238732","NCT01436513","NCT00706225","NCT00465894","NCT01648751","NCT00381251","NCT00137371","NCT01613170","NCT00401219","NCT02213757","NCT02431897","NCT00167921","NCT00484107"],"aliases":[],"patents":[],"pricing":[],"allNames":"vaginal estrogen","offLabel":[],"timeline":[{"date":"2006","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopa) — Endometrial Hyperplasia"},{"date":"2008","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Wom) — Postmenopause"},{"date":"2015","type":"negative","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)) — Microscopic Hematuria. Trial terminated early."}],"aiSummary":"Vaginal estrogen is a small molecule modality that is used to treat various conditions, including Polycystic Ovary Syndrome (PCOS), Stress Urinary Incontinence, and Postmenopausal Disorder. It is administered via vaginal route and is classified as a type of estrogen.","brandName":"Vaginal estrogen","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter","explanation":"","oneSentence":"1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"vaginal-estrogen","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Pelvic Organ Prolapse","phase":"discontinued","trialId":"","patients":null,"diseaseId":"womens-health","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00675688","phase":"Phase 3","title":"Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopa","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":true,"enrollment":3544,"indication":"Endometrial Hyperplasia","completionDate":"2006-01","primaryEndpoint":"The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in p"},{"nctId":"NCT00238732","phase":"Phase 3","title":"Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":650,"indication":"Vaginal Atrophy","completionDate":"","primaryEndpoint":"The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy."},{"nctId":"NCT01436513","phase":"Phase 1","title":"A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Hea","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":72,"indication":"Primary Ovarian Insufficiency","completionDate":"2012-03","primaryEndpoint":"The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women."},{"nctId":"NCT00706225","phase":"Phase 1","title":"Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Wom","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":30,"indication":"Postmenopause","completionDate":"2008-07","primaryEndpoint":"Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis."},{"nctId":"NCT00465894","phase":"N/A","title":"Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms","status":"Completed","sponsor":"University of Alabama at Birmingham","isPivotal":false,"enrollment":58,"indication":"Overactive Bladder","completionDate":"2010-07","primaryEndpoint":"The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment"},{"nctId":"NCT01648751","phase":"N/A","title":"Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse","status":"Terminated","sponsor":"Pamela Moalli","isPivotal":false,"enrollment":21,"indication":"Pelvic Organ Prolapse","completionDate":"2023-03","primaryEndpoint":"This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a com"},{"nctId":"NCT00381251","phase":"Phase 1","title":"Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference F","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":null,"indication":"Postmenopausal Osteoporosis","completionDate":"","primaryEndpoint":"This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and m"},{"nctId":"NCT00137371","phase":"Phase 3","title":"Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":480,"indication":"Atrophic Vaginitis","completionDate":"","primaryEndpoint":"This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis."},{"nctId":"NCT01613170","phase":"Phase 4","title":"Premarin Versus Toviaz for Treatment of Overactive Bladder","status":"Unknown","sponsor":"The Cleveland Clinic","isPivotal":false,"enrollment":90,"indication":"Overactive Bladder","completionDate":"2018-04","primaryEndpoint":"The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the use of Toviaz alone for the treatment of overactive bladder."},{"nctId":"NCT00401219","phase":"Phase 1","title":"Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Re","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":null,"indication":"Estrogen Replacement Therapy","completionDate":"","primaryEndpoint":"This study will compare the bioavailabity of three new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and "},{"nctId":"NCT02213757","phase":"Phase 4","title":"Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)","status":"Terminated","sponsor":"Medstar Health Research Institute","isPivotal":false,"enrollment":29,"indication":"Microscopic Hematuria","completionDate":"2015-12","primaryEndpoint":"The purpose of this study is to determine if vaginal estrogen use is associated with resolution of blood in the urine (microscopic hematuria) in postmenopausal women."},{"nctId":"NCT02431897","phase":"Phase 4","title":"Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen","status":"Completed","sponsor":"University of Texas Southwestern Medical Center","isPivotal":false,"enrollment":206,"indication":"Pelvic Organ Prolapse","completionDate":"2021-11","primaryEndpoint":"This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative va"},{"nctId":"NCT00167921","phase":"Phase 1","title":"Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":24,"indication":"Atrophic Vaginitis","completionDate":"","primaryEndpoint":"The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atro"},{"nctId":"NCT00484107","phase":"N/A","title":"Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":200,"indication":"Postmenopause","completionDate":"","primaryEndpoint":"This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL592868"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":4,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}