Skip to main content
OpenTrials
Completed

NCT Number: NCT02013544

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

Completed

Looking for future studies?

Notify Me

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–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

EndoCeutics site # 85, Burlington, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Main criteria:

  • Postmenopausal women (hysterectomized or not)
  • Women between 40 and 80 years of age
  • Women having ≤5% of superficial cells on vaginal smear at baseline
  • Women having a vaginal pH above 5 at baseline
  • Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
  • Willing to participate in the study and sign an informed consent

Exclusion criteria

Main criteria:

  • Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
  • Previous diagnosis of cancer, except skin cancer (non melanoma)
  • Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
  • The administration of any investigational drug within 30 days of screening visit
  • Clinically significant abnormal serum biochemistry, urinalysis or hematology

Treatment and study plan

Placebo

Drug

Prasterone (DHEA)

Drug

Primary outcomes

  1. Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear

    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.

  2. Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

    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.

  3. Change From Baseline to Week 12 in Vaginal pH

    Time frame: Baseline and Week 12

    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.

  4. Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia

    Time frame: Baseline and Week 12

    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.

Secondary outcomes

  1. Change From Baseline to Week 12 in Severity of Vaginal Dryness

    Time frame: Baseline and Week 12

    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.

  2. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions

    Time frame: Baseline and Week 12

    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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.

  3. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity

    Time frame: Baseline and Week 12

    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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.

  4. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness

    Time frame: Baseline and Week 12

    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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.

  5. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color

    Time frame: Baseline and Week 12

    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2013
Registry last updated
Jun 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.