At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 540 enrolled
Drug / intervention
Estrace® Cream +2 moredrug
Likely dose
Not stated in 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.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy
In Brief
A Phase 3 clinical trial evaluating Estrace® Cream, Estradiol Vaginal Cream, and 1 other intervention for Vulvar and Vaginal Atrophy. Completed, enrolled 540 participants across 27 sites.
Detailed Summary
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar and Vaginal Atrophy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedNov 2017
Primary CompletionMar 2018
TodayJul 2026
First PostedNov 6, 2017
Enrollment StartOct 26, 2017
Primary CompletionMar 15, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.7 years ago
Interventions
Estrace® Creamdrug
Estrace® Cream
Estradiol Vaginal Creamdrug
Estradiol Vaginal Cream
Vehicle Creamdrug
Vehicle Cream