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Androgen

0.5% DHEA for Vulvovaginal Atrophy

Phase 3
Waitlist Available
Led By David Archer, MD
Research Sponsored by EndoCeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

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

Eligible Conditions
  • Vulvovaginal Atrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
+1 more
Secondary study objectives
Change From Baseline to Week 12 in Severity of Dyspareunia
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
+2 more

Side effects data

From 2012 Phase 3 trial • 530 Patients • NCT01256671
14%
Application site discharge
10%
Urinary tract infection
10%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.50% DHEA

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.5% DHEAExperimental Treatment1 Intervention
Group II: 0.25% DHEAExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prasterone
FDA approved

Find a Location

Who is running the clinical trial?

EndoCeutics Inc.Lead Sponsor
9 Previous Clinical Trials
2,492 Total Patients Enrolled
David Archer, MDPrincipal InvestigatorClinical Research Center, Eastern Virginia Medical School, Norfolk, VA
2 Previous Clinical Trials
476 Total Patients Enrolled
~31 spots leftby Oct 2025
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