DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Study Overview
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Brief Summary
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The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Official Title
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DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)

Conditions
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Vaginal Atrophy

Intervention / Treatment
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* Drug: Placebo
* Drug: DHEA
* Drug: DHEA


Participation Criteria
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Eligibility Criteria
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Main 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. Main 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.

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<br>|
| Experimental: 0.25% DHEA<br> | Drug: DHEA<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<br>* Vaginal suppository containing 0.50% (6.5 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 |
| --- | --- | --- |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 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. | Baseline and Week 12 | 
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | 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. | Baseline and Week 12 | 
| Change From Baseline to Week 12 in Vaginal pH | 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. | Baseline and Week 12 | 
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | 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. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in Severity of Vaginal Dryness | The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness 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 | 
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, 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 then 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, 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 then analyzed using the 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