Trial record 14 of 28 for:    Porencephaly

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
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 April 16, 2014