DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Status: | Completed |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 40 - 75 |
Updated: | 10/20/2017 |
Start Date: | December 2010 |
End Date: | December 2012 |
The purpose of this Phase III trial is to assess the long-term safety of intravaginal
dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal
atrophy aged 40 to 75 years.
dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal
atrophy aged 40 to 75 years.
Main Inclusion Criteria:
- Postmenopausal women (non-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.
- Willing to have endometrial biopsy at screening and end of study (Week 52).
Main 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
30
sites
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