Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EndoCeutics Inc.
• Treatments: Dehydroepiandrosterone

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