Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

EndoCeutics

Status and phase: Completed; Phase 3

Conditions: Vaginal Atrophy

Treatments: Drug: DHEA; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358760

ERC-234

Details and patient eligibility

About

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

Enrollment: 450 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

450 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

0.25% DHEA

Experimental group

Treatment:

Drug: DHEA

0.5% DHEA

Experimental group

Treatment:

Drug: DHEA