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: May 2, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

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 and superficial cells; maturation value) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Co-primary endpoint: change from baseline over time of vaginal pH. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Co-primary endpoint: change from baseline over time in the moderate to severe symptom of vaginal atrophy identified by the subject as most bothersome to her. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local tolerance to intravaginal administration of DHEA. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline over time in quality of life evaluated by the Menopause Specific Quality of Life (MENQOL) questionnaire. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline over time in sexual function evaluated by the Abbreviated Sexual Function (ASF), the Sexual Concern (SC) and the Psychological General Well-Being (PGWB) questionnaires. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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, Vaginorm
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, Vaginorm
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, Vaginorm
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, Vaginorm

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders 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
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 01, 2014