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DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

NCT01256684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2017-06-26

Study results available
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Summary

The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Conditions

  • Vaginal Atrophy

Interventions

DRUG

Placebo

Placebo vaginal suppository

DRUG

DHEA

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

DRUG

DHEA

Vaginal suppository containing 0.50% (6.5 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 School, 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
2010-12-31
Primary Completion
2011-08-31
Completion
2011-11-30

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 NCT01256684 on ClinicalTrials.gov