Overview

DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this Phase III trial is to confirm 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
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.