Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy | NCT01358760 | Trialant
CompletedInterventionalPhase 3Updated Jun 12, 2017
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
ClinicalTrials.gov ID
NCT01358760
Lead Sponsor
EndoCeutics Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
450Actual
Last Update Posted
Jun 12, 2017Actual
Start Date
Jun 2011
Primary Completion Date
Apr 2012Actual
Completion Date
May 2012Actual
Brief Summary
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Vaginal Atrophy
Placebo
DHEA
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No
Eligibility 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 who have self-identified symptom(s) of vaginal atrophy
For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study
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