At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 558 enrolled
Drug / intervention
Placebo +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.
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
In Brief
A Phase 3 clinical trial evaluating Placebo and Prasterone (DHEA) for Vaginal Atrophy. Completed, enrolled 558 participants across 38 sites in 2 countries.
Detailed Summary
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Atrophy
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartFeb 2014
Primary CompletionJan 2015
Study CompletionFeb 2015
TodayJul 2026
First PostedDec 17, 2013
Enrollment StartFeb 1, 2014
Primary CompletionJan 1, 2015
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.5 years ago
Interventions
Placebodrug
Prasterone (DHEA)drug