Topical DHEA Against Vaginal Atrophy

Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

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.

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