MedTrace Logo

Topical DHEA Against Vaginal Atrophy

NCT01846442 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2017-08-29

Study results available
· View outcomes & findings →

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.

Conditions

  • Vaginal Atrophy

Interventions

DRUG

Placebo

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

DRUG

DHEA (0.25%)

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

DRUG

DHEA (0.5%)

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

DRUG

DHEA (1.0%)

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

Sponsors & Collaborators

  • EndoCeutics Inc.

    lead INDUSTRY

Principal Investigators

  • David F Archer, MD · Clinical Research Center, Eastern Virginia Medical Scholl, Norfolk, VA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-05-31
Completion
2008-10-31

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 NCT01846442 on ClinicalTrials.gov