Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Vaginal Atrophy
- Sponsor
- EndoCeutics Inc.
- Enrollment
- 218
- Locations
- 8
- Primary Endpoint
- Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
Investigators
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 having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
- •Women having a vaginal pH above 5
- •Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy
Exclusion Criteria
- •Undiagnosed abnormal genital bleeding
- •Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
- •The administration of any investigational drug within 30 days of screening visit
- •Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
- •Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
Arms & Interventions
Placebo
Intervention: Placebo
0.25% DHEA
Intervention: DHEA (0.25%)
0.5% DHEA
Intervention: DHEA (0.5%)
1.0% DHEA
Intervention: DHEA (1.0%)
Outcomes
Primary Outcomes
Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
Time Frame: Baseline and Week 12
The severity of dyspareunia was evaluated by a questionnaire. 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.
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)
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.
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
Time Frame: Baseline and Week 12
A pH strip was applied directly to the lateral wall of the vagina using forceps. 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.
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)
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.
Secondary Outcomes
- Change From Baseline to Week 12 of Vaginal Secretions(Baseline and Week 12)
- Change From Baseline to Week 12 of Vaginal Epithelial Integrity(Baseline and Week 12)
- Change From Baseline to Week 12 of Vaginal Color(Baseline and Week 12)
- Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness(Baseline and Week 12)