Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EndoCeutics Inc.
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion Criteria:

Main criteria:

• Postmenopausal women (hysterectomized or not)

• Women between 40 and 80 years of age

• Women having ≤5% of superficial cells on vaginal smear at baseline

• Women having a vaginal pH above 5 at baseline

• Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

• Willing to participate in the study and sign an informed consent

Exclusion Criteria:

Main criteria:

• Previous enrollment in EndoCeutics studies performed with intravaginal DHEA

• Previous diagnosis of cancer, except skin cancer (non melanoma)

• Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication

• The administration of any investigational drug within 30 days of screening visit

• Clinically significant abnormal serum biochemistry, urinalysis or hematology