CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 722 enrolled
Drug / intervention
WC3011 Estradiol Vaginal Cream +1 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.

Search/NCT01400776
NCT01400776Phase 3Completed

A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

Warner Chilcott·interventional·Posted Jul 22, 2011·Updated May 9, 2022

In Brief

A Phase 3 clinical trial evaluating WC3011 Estradiol Vaginal Cream and Vehicle for Postmenopausal Vulvovaginal Atrophy. Completed, enrolled 722 participants across 70 sites.

Detailed Summary

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2011
Enrollment StartJun 29, 2011
Primary CompletionFeb 27, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.9 years ago

Interventions

WC3011 Estradiol Vaginal Creamdrug

WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks

Vehicledrug

Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.