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DHEA Against Vaginal Atrophy - Safety Study of 12 Months

NCT01256671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2017-10-18

Study results available
· View outcomes & findings →

Summary

The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Conditions

  • Vaginal Atrophy

Interventions

DRUG

DHEA

Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

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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 NCT01256671 on ClinicalTrials.gov