DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Vaginal Atrophy
- Sponsor
- EndoCeutics Inc.
- Enrollment
- 255
- Locations
- 33
- Primary Endpoint
- Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Postmenopausal women (hysterectomized or non-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 screening 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.
Arms & Interventions
Placebo
Intervention: Placebo
0.25% DHEA
Intervention: DHEA
0.5% DHEA
Intervention: DHEA
Outcomes
Primary Outcomes
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 cell 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 the 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 Superficial Cells in the Maturation Index of the Vaginal Smear
Time Frame: Baseline and Week 12
The percentage of superficial cell 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 the 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.
Secondary Outcomes
- Change From Baseline to Week 12 in Severity of Vaginal Dryness(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color(Baseline and Week 12)