At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 550 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.
A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
In Brief
A Phase 3 clinical trial evaluating WC3011 Estradiol Vaginal Cream and Vehicle for Vulvovaginal Atrophy. Completed, enrolled 550 participants across 57 sites.
Detailed Summary
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Atrophy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedMay 2013
Primary CompletionNov 2013
TodayJul 2026
First PostedMay 3, 2013
Enrollment StartApr 12, 2013
Primary CompletionNov 20, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.2 years ago
Interventions
WC3011 Estradiol Vaginal Creamdrug
Daily for 14 days followed by 3 times per week for 10 weeks
Vehicledrug
Daily for 14 days followed by 3 times per week for 10 weeks