NCT02013544

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

Completed Phase 3 Results posted Last updated 30 May 2017

What this trial tests

Phase 3 trial testing Placebo in Vaginal Atrophy in 558 participants. Completed in 1 February 2015.

Timeline

1 February 2014

Primary endpoint
1 January 2015

1 February 2015

Quick facts

Lead sponsor	EndoCeutics Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	558
Start date	1 February 2014
Primary completion	1 January 2015
Estimated completion	1 February 2015
Sites	38 locations across United States, Canada

Drugs / interventions tested

• Placebo
• Prasterone (DHEA) — full drug profile →

Conditions studied

• Vaginal Atrophy — all drugs for Vaginal Atrophy →

Sponsor

EndoCeutics Inc. — full company profile →

Who can join

Adults 40 to 80, female only, with Vaginal Atrophy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
  Time frame: Baseline and Week 12
  The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
• Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
  Time frame: Baseline and Week 12
  The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
• Change From Baseline to Week 12 in Vaginal pH
  Time frame: Baseline and Week 12
  A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
• Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
  Time frame: Baseline and Week 12
  The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dehydroepiandrosterone for women in the peri- or postmenopausal phase.
   Scheffers CS, Armstrong S, Cantineau AE, Farquhar C, et al · · 2015 · cited 22× · PMID 25879093 · DOI 10.1002/14651858.cd011066.pub2