Topical DHEA Against Vaginal Atrophy

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from 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 having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)

• Women having a vaginal pH above 5

• Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy

Exclusion Criteria:

• Undiagnosed abnormal genital bleeding

• Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy

• The administration of any investigational drug within 30 days of screening visit

• Endometrial hyperplasia at biopsy performed at screening or endometrial cancer

• Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry