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Completed

NCT Number: NCT01846442

Topical DHEA Against Vaginal Atrophy

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.

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Key information

Conditions

Vaginal Atrophy Atrophic Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

EndoCeutics site # 09, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Other names: Prasterone, Dehydroepiandrosterone

DHEA (0.25%)

Drug

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

Other names: Prasterone, Dehydroepiandrosterone

DHEA (0.5%)

Drug

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

Other names: Prasterone, Dehydroepiandrosterone

DHEA (1.0%)

Drug

Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.

Other names: Prasterone, Dehydroepiandrosterone

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change From Baseline to Week 12 of Vaginal Secretions

    Time frame: Baseline and Week 12

    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.

  2. Change From Baseline to Week 12 of Vaginal Epithelial Integrity

    Time frame: Baseline and Week 12

    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.

  3. Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness

    Time frame: Baseline and Week 12

    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.

  4. Change From Baseline to Week 12 of Vaginal Color

    Time frame: Baseline and Week 12

    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.

Sponsors and collaborators

Lead sponsor

EndoCeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 3, 2013
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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