DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Status:	Completed
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	40 - 75
Updated:	4/21/2016
Start Date:	December 2010
End Date:	November 2011

DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)

The purpose of this Phase III trial is to confirm the efficacy of intravaginal
dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Main Inclusion Criteria:

- Postmenopausal women (hysterectomized or 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.

- For non-hysterectomized women, willing to have endometrial biopsy at screening and
end of study.

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

sites

EndoCeutics site # 45

Boynton Beach, Florida 33472

from

Boynton Beach, FL