At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 530 enrolled
Drug / intervention
DHEAdrug
Likely dose
DHEA 6.5 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 - Safety Study of 12 Months
In Brief
A Phase 3 clinical trial evaluating DHEA for Vaginal Atrophy. Completed, enrolled 530 participants across 41 sites in 2 countries.
Detailed Summary
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
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 CompletionJul 2012
Study CompletionDec 2012
TodayJul 2026
First PostedDec 8, 2010
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.6 years ago
Interventions
DHEAdrug
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.