Phase 3 N=450 Randomized Quadruple-blind Treatment

Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

Vaginal Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT01358760 ↗

Enrolled (actual)

450

Serious AEs

1.6%

Results posted

Jun 2017

Primary outcome: Primary: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear — 60.66; 56.74; 59.54; 62.22 percentage of parabasal cells

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); DHEA (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: EndoCeutics Inc.
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear	60.66; 56.74; 59.54; 62.22; 39.23; 33.02	—
PRIMARY Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear	0.97; 1.12; 0.93; 1.80; 3.43; 3.58	—
PRIMARY Change From Baseline to Week 12 in Vaginal pH	6.34; 6.27; 6.29; 6.06; 5.69; 5.67	—
PRIMARY Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness	2.38; 2.37; 2.35; 1.27; 1.10; 1.13	—
SECONDARY Change From Baseline to Week 12 in Severity of Dyspareunia	2.56; 2.58; 2.60; 1.78; 1.48; 1.54	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions	2.71; 2.55; 2.55; 2.33; 2.07; 2.07	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity	2.32; 2.19; 2.19; 1.94; 1.74; 1.69	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness	2.78; 2.66; 2.72; 2.40; 2.25; 2.16	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color	2.66; 2.60; 2.65; 2.31; 2.16; 2.12	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Postmenopausal women (non-hysterectomized or hysterectomized)
Women between 40 and 75 years of age
Willing to participate in the study and sign an informed consent
Women who have self-identified symptom(s) of vaginal atrophy
For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study

Exclusion Criteria

Undiagnosed abnormal genital bleeding
Hypertension equal to or above 140/90 mm Hg
The administration of any investigational drug within 30 days of screening visit
Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01358760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.