CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 218 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Placebo 0 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.

Search/NCT01846442
NCT01846442Phase 3Completed
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Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

EndoCeutics Inc.·interventional·Posted May 3, 2013·Updated Aug 29, 2017

In Brief

A Phase 3 clinical trial evaluating Placebo, DHEA (0.25%), and 2 other interventions for Vaginal Atrophy. Completed, enrolled 218 participants across 8 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Atrophy
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2013
Enrollment StartJun 1, 2007
Primary CompletionMay 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.2 years ago

Interventions

Placebodrug

Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.

DHEA (0.25%)drug

Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.

DHEA (0.5%)drug

Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

DHEA (1.0%)drug

Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.