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DHEA Against Vaginal Atrophy - Safety Study of 12 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.
ClinicalTrials.gov Identifier:
NCT01256671
First received: December 3, 2010
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.


Condition Intervention Phase
Vaginal Atrophy
Drug: DHEA
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DHEA Against Vaginal Atrophy - Safety Study of 12 Months

Resource links provided by NLM:


Further study details as provided by EndoCeutics Inc.:

Primary Outcome Measures:
  • Change from baseline over time of clinical safety data: adverse event (AE) reporting, vital signs, physical examination findings, gynecological examination findings, clinical laboratory tests, endometrial biopsy, mammography and Pap smear. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline over time of vaginal cell maturation (percentage of parabasal and superficial cells). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline over time of vaginal pH. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline over time of self-assessment of symptoms of vulvar/vaginal atrophy. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 530
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHEA
0.5% DHEA (intravaginal)
Drug: DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 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 (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.
  • Willing to have endometrial biopsy at screening and end of study (Week 52).

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: NCT01256671

  Show 43 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: NCT01256671     History of Changes
Other Study ID Numbers: ERC-230
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014