DHEA Against Vaginal Atrophy - Safety Study of 12 Months

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: EndoCeutics Inc.
• Treatments: Dehydroepiandrosterone

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.