Topical DHEA Against Vaginal Atrophy

Phase 3CompletedNCT01846442

EndoCeutics Inc.218 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

218

Conditions

Vaginal Atrophy

Interventions

Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.

DHEA (0.25%)DRUG

Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.

DHEA (0.5%)DRUG

Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (8)

EndoCeutics site # 05

Cleveland, Ohio, United States

EndoCeutics site # 03

Norfolk, Virginia, United States

EndoCeutics site # 10

Montreal, Quebec, Canada

EndoCeutics site # 09

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Week 12

Secondary Outcomes

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Week 12

NCT01846442 - Topical DHEA Against Vaginal Atrophy | Crick | Crick