DHEA Against Vaginal Atrophy - Safety Study of 12 Months

EndoCeutics

Status and phase

Completed

Phase 3

Conditions

Vaginal Atrophy

Treatments

Drug: DHEA

Study type

Interventional

Funder types

Industry

Identifiers

NCT01256671

ERC-230

Details and patient eligibility

About

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.

Enrollment

530 patients

Sex

Female

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.