At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 576 enrolled
Drug / intervention
Vehicle +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.
A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women
In Brief
A Phase 3 clinical trial evaluating Vehicle and WC3011 Estradiol Vaginal Cream for Vulvovaginal Atrophy. Completed, enrolled 576 participants across 48 sites.
Detailed Summary
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Atrophy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedMar 2013
Primary CompletionNov 2013
TodayJul 2026
First PostedMar 21, 2013
Enrollment StartJan 31, 2013
Primary CompletionNov 19, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.3 years ago
Interventions
Vehicledrug
Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks
WC3011 Estradiol Vaginal Creamdrug
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks