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Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

NCT02013544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2017-06-01

Study results available
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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.

Conditions

  • Vaginal Atrophy

Interventions

DRUG

Placebo

DRUG

Prasterone (DHEA)

Sponsors & Collaborators

  • EndoCeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Fernand Labrie, M.D., Ph.D. · EndoCeutics Inc.

  • David F Archer, M.D. · Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013544 on ClinicalTrials.gov