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 |
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.
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
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