CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 464 enrolled
Drug / intervention
prasterone +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.

Search/NCT01376349
NCT01376349Phase 3Completed
CompareCT.gov

Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial

Alliance for Clinical Trials in Oncology·interventional·Posted Jun 20, 2011·Updated Feb 7, 2019

In Brief

A Phase 3 clinical trial evaluating prasterone and placebo for Breast Cancer and Gynecologic Cancer. Completed, enrolled 464 participants across 280 sites.

Detailed Summary

RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors. PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Gynecologic Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Mayo Clinic

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 20, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2013
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.0 years ago

Interventions

prasteronedrug

Applied vaginally

placeboother

Applied vaginally