At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 255 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
DHEA 3.25 mgfrom 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.
DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)
In Brief
A Phase 3 clinical trial evaluating Placebo and DHEA for Vaginal Atrophy. Completed, enrolled 255 participants across 33 sites in 2 countries.
Detailed Summary
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Atrophy
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedDec 2010
Primary CompletionAug 2011
Study CompletionNov 2011
TodayJul 2026
First PostedDec 8, 2010
Enrollment StartDec 1, 2010
Primary CompletionAug 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.6 years ago
Interventions
Placebodrug
Placebo vaginal suppository
DHEAdrug
Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEAdrug
Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.