DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

EndoCeutics

Status and phase: Completed; Phase 3

Conditions: Vaginal Atrophy

Treatments: Drug: DHEA; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01256684

ERC-231

Details and patient eligibility

About

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

Enrollment: 255 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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255 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

0.25% DHEA

Experimental group

Treatment:

Drug: DHEA

Drug: DHEA

0.5% DHEA

Experimental group

Treatment:

Drug: DHEA

Drug: DHEA