Dehydroepiandrosterone (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 2011 |
End Date: | May 2012 |
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal
dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
dehydroepiandrosterone (DHEA) in postmenopausal women with 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 who have self-identified symptom(s) of vaginal atrophy
- For non-hysterectomized women, willing to have endometrial biopsy at baseline and end
of study
Exclusion Criteria:
- Undiagnosed abnormal genital bleeding
- Hypertension equal to or above 140/90 mm Hg
- The administration of any investigational drug within 30 days of screening visit
- Endometrial hyperplasia, cancer or endometrial histology showing proliferative,
secretory or menstrual type characteristics at histologic evaluation of endometrial
biopsy performed at screening
We found this trial at
31
sites
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