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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
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 moreSecondary 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 moreSide effects data
From 2012 Phase 3 trial • 530 Patients • NCT0125667114%
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
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