Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

• Status: Withdrawn
• Trial end date: 2019-12-05
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.

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

Details

• Lead Sponsor: EndoCeutics Inc.
• Collaborator: AMAG Pharmaceuticals, Inc.
• Treatments: Aromatase Inhibitors; Dehydroepiandrosterone

Criteria

Inclusion Criteria:

Main criteria:

1. Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study.

2. Women between 30 and 80 years of age

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

4. Women having a vaginal pH above 5 at baseline

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

Exclusion Criteria:

Main criteria:

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

2. The administration of any investigational drug within 30 days of screening visit