Topical DHEA Against Vaginal Atrophy

Study Overview
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Brief Summary
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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.

Official Title
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Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

Conditions
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Vaginal Atrophy

Intervention / Treatment
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* Drug: Placebo
* Drug: DHEA (0.25%)
* Drug: DHEA (0.5%)
* Drug: DHEA (1.0%)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.<br>* Other names: Prasterone, Dehydroepiandrosterone;|
| Experimental: 0.25% DHEA<br> | Drug: DHEA (0.25%)<br>* Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.<br>* Other names: Prasterone, Dehydroepiandrosterone;|
| Experimental: 0.5% DHEA<br> | Drug: DHEA (0.5%)<br>* Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.<br>* Other names: Prasterone, Dehydroepiandrosterone;|
| Experimental: 1.0% DHEA<br> | Drug: DHEA (1.0%)<br>* Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.<br>* Other names: Prasterone, Dehydroepiandrosterone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 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. | Baseline and Week 12 | 
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | 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. | Baseline and Week 12 | 
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | 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. | Baseline and Week 12 | 
| Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | 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. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 of Vaginal Secretions | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. | Baseline and Week 12 | 
| Change From Baseline to Week 12 of Vaginal Epithelial Integrity | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. | Baseline and Week 12 | 
| Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial surface thickness(one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. | Baseline and Week 12 | 
| Change From Baseline to Week 12 of Vaginal Color | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvar/vaginal atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa