Topical DHEA Against Vaginal Atrophy



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:40 - 75
Updated:4/21/2016
Start Date:June 2007
End Date:October 2008

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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 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
We found this trial at
3
sites
Cleveland, Ohio 44122
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Cleveland, OH
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Montreal, Quebec
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Montreal,
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Norfolk, Virginia 23507
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Norfolk, VA
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