At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 366 enrolled
Drug / intervention
Estradiol Vaginal Cream, 0.01% +2 moredrug
Likely dose
Estradiol Vaginal Cream, 0.01% 2gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Mylan) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
In Brief
A Phase 3 clinical trial evaluating Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream, and 1 other intervention for Atrophic Vaginitis. Completed, enrolled 366 participants across 21 sites.
Detailed Summary
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophic Vaginitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJul 2014
Primary CompletionDec 2014
TodayJul 2026
First PostedJul 21, 2014
Enrollment StartJun 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.9 years ago
Interventions
Estradiol Vaginal Cream, 0.01%drug
Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days)
Estrace® 0.01% creamdrug
Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days)
Placebo Vaginal Creamdrug
Placebo Vaginal Cream ( 1 x 2 g for 7 days)