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: May 1, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 and superficial cells). [ 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 of self-assessment of symptoms of vulvar/vaginal atrophy. [ 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 ]

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, Vaginorm
Experimental: 0.5% DHEA Drug: DHEA
Vaginal suppository containing 0.5% (6.5 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

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 35 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
Last Updated: May 1, 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