Phase 3 N=558 Randomized Quadruple-blind Treatment

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

Vaginal Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT02013544 ↗

Enrolled (actual)

558

Serious AEs

0.9%

Results posted

Jun 2017

Primary outcome: Primary: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear — 1.04; 1.02; 2.78; 11.22 Percentage of superficial cells

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Prasterone (DHEA) (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: EndoCeutics Inc.
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear	1.04; 1.02; 2.78; 11.22; 1.75; 10.20	—
PRIMARY Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear	51.66; 54.25; 39.68; 12.74; -11.98; -41.51	—
PRIMARY Change From Baseline to Week 12 in Vaginal pH	6.32; 6.34; 6.05; 5.39; -0.27; -0.94	—
PRIMARY Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia	2.56; 2.54; 1.50; 1.13; -1.06; -1.42	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Dryness	2.30; 2.30; 1.13; 0.86; -1.17; -1.44	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions	2.63; 2.70; 2.24; 1.97; -0.39; -0.73	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity	2.43; 2.45; 2.06; 1.75; -0.37; -0.69	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness	2.76; 2.83; 2.41; 2.09; -0.36; -0.74	—
SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color	2.67; 2.75; 2.34; 2.03; -0.33; -0.73	—

Summary

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

Eligibility Criteria

Inclusion Criteria

Main criteria:

Postmenopausal women (hysterectomized or not)
Women between 40 and 80 years of age
Women having ≤5% of superficial cells on vaginal smear at baseline
Women having a vaginal pH above 5 at baseline
Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
Willing to participate in the study and sign an informed consent

Exclusion Criteria

Main criteria:

Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
Previous diagnosis of cancer, except skin cancer (non melanoma)
Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
The administration of any investigational drug within 30 days of screening visit
Clinically significant abnormal serum biochemistry, urinalysis or hematology

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02013544). 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.