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Topical DHEA Against Vaginal Atrophy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.
ClinicalTrials.gov Identifier:
NCT01846442
First received: May 1, 2013
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Vaginal Atrophy
Drug: Placebo
Drug: DHEA (0.25%)
Drug: DHEA (0.5%)
Drug: DHEA (1.0%)
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: Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

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 % 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.


  • 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 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.


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

    Decrease 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.


  • 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 vulvovaginal atrophy):

    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.



Secondary Outcome Measures:
  • Change From Baseline Over Time of Vaginal Secretions [ Time Frame: 12 weeks ]

    Improvement 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.


  • Change From Baseline Over Time of Vaginal Epithelial Integrity [ Time Frame: 12 weeks ]

    Improvement 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.


  • Change From Baseline Over Time of Vaginal Epithelial Surface Thickness [ Time Frame: 12 weeks ]

    Improvement 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.


  • Change From Baseline Over Time of Vaginal Color [ Time Frame: 12 weeks ]

    Improvement 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.



Enrollment: 218
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
Other Name: Prasterone, Dehydroepiandrosterone
Experimental: 0.25% DHEA Drug: DHEA (0.25%)
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 (0.5%)
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Other Name: Prasterone, Dehydroepiandrosterone
Experimental: 1.0% DHEA Drug: DHEA (1.0%)
Vaginal suppository containing 1.0% (13 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

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
  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: NCT01846442

Locations
United States, Ohio
EndoCeutics site # 05
Cleveland, Ohio, United States, 44122
United States, Virginia
EndoCeutics site # 03
Norfolk, Virginia, United States, 23507
Canada, Quebec
EndoCeutics site # 10
Montreal, Quebec, Canada, H1T 1P6
EndoCeutics site # 09
Montreal, Quebec, Canada, H3A 1A1
EndoCeutics site # 08
Shawinigan, Quebec, Canada, G9N 2H6
EndoCeutics site # 11
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
EndoCeutics site # 02
Quebec, Canada, G1S 2L6
EndoCeutics site # 01
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
EndoCeutics Inc.
Investigators
Principal Investigator: David F Archer, MD Clinical Research Center, Eastern Virginia Medical Scholl, Norfolk, VA
  More Information

Publications:

Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT01846442     History of Changes
Other Study ID Numbers: ERC-210
Study First Received: May 1, 2013
Results First Received: March 20, 2017
Last Updated: March 20, 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 25, 2017