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DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.
ClinicalTrials.gov Identifier:
NCT01256684
First received: December 3, 2010
Last updated: March 14, 2017
Last verified: March 2017
  Purpose
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Condition Intervention Phase
Vaginal Atrophy
Drug: Placebo
Drug: DHEA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)

Resource links provided by NLM:


Further study details as provided by EndoCeutics Inc.:

Primary Outcome Measures:
  • Co-primary Endpoint: Change From Baseline Over Time of Vaginal Cell Maturation (Percentage of Parabasal Cells). [ Time Frame: 12 weeks ]

    Decrease in Percentage of Parabasal Cells:

    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.


  • Co-primary Endpoint: Change From Baseline Over Time of Vaginal Cell Maturation (Percentage of Superficial Cells). [ Time Frame: 12 weeks ]

    Increase in % of Superficial Cells:

    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.


  • Co-primary Endpoint: Change From Baseline Over Time of Vaginal pH. [ Time Frame: 12 weeks ]

    Decrease of 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.


  • Co-primary Endpoint: Change From Baseline Over Time of Self-assessment of the Most Bothersome Symptom Dyspareunia. [ Time Frame: 12 weeks ]

    Decrease in the severity of dyspareunia (self-identified by the subject as the most bothersome symptom of vaginal atrophy):

    The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using score values of 0, 1, 2 or 3, respectively.



Secondary Outcome Measures:
  • Change From Baseline Over Time of Self-assessment of Vaginal Dryness. [ Time Frame: 12 weeks ]

    Decrease in the severity of vaginal dryness:

    The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using score values of 0, 1, 2 or 3, respectively.


  • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Secretions) [ Time Frame: 12 weeks ]

    Improvement of 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.


  • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Epithelial Integrity) [ Time Frame: 12 weeks ]

    Improvement of the 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.


  • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Epithelial Surface Thickness) [ Time Frame: 12 weeks ]

    Improvement of the 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.


  • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Color) [ Time Frame: 12 weeks ]

    Improvement of the 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.



Enrollment: 255
Study Start Date: December 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo vaginal suppository
Experimental: 0.25% DHEA Drug: DHEA
Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
Other Name: Prasterone, Dehydroepiandrosterone
Experimental: 0.5% DHEA Drug: DHEA
Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Other Name: Prasterone, Dehydroepiandrosterone

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256684

  Show 33 Study Locations
Sponsors and Collaborators
EndoCeutics Inc.
Investigators
Principal Investigator: David F Archer, MD Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
  More Information

Publications:
Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT01256684     History of Changes
Other Study ID Numbers: ERC-231
Study First Received: December 3, 2010
Results First Received: March 14, 2017
Last Updated: March 14, 2017

Keywords provided by EndoCeutics Inc.:
Vulvar/vaginal atrophy
Atrophic Vaginitis
Dehydroepiandrosterone
DHEA
Prasterone
Vaginorm
Menopause
Intrarosa

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017