Topical DHEA Against Vaginal Atrophy

Completed · Phase 3 · Has a placebo group

Conditions studied: Vaginal Atrophy

In brief

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.

Key facts

Study ID

NCT01846442

Run by

EndoCeutics Inc.

People needed

218

Starts

2007-06-01

Expected to finish

2008-10-01

Last updated by the study team

2017-08-29

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• EndoCeutics site # 05 — Cleveland, Ohio, United States
• EndoCeutics site # 03 — Norfolk, Virginia, United States
• EndoCeutics site # 10 — Montreal, Quebec, Canada
• EndoCeutics site # 09 — Montreal, Quebec, Canada
• EndoCeutics site # 08 — Shawinigan, Quebec, Canada
• EndoCeutics site # 11 — Sherbrooke, Quebec, Canada
• EndoCeutics site # 02 — Québec, Canada
• EndoCeutics site # 01 — Québec, Canada

Full record on ClinicalTrials.gov

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