Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors

PHASE2TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 7, 2021

Primary Completion Date

July 18, 2023

Study Completion Date

July 18, 2023

Conditions
Vaginal AtrophyPostmenopausal SymptomsBreast Cancer FemaleLong-term Survivors
Interventions
DRUG

Vaginal Dehydroepiandrosterone

This is a vaginally administered suppository steroid indicated for the treatment of moderate to severe dyspareunia, a frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause.

COMBINATION_PRODUCT

Vaginal Polycarbophil Moisturizer

This is an FDA cleared, over-the-counter personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is non-sterile, water-based, non-irritating, non-greasy, non-staining vaginal gel delivered as a long-lasting moisturizer for vaginal dryness.

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Little Rock

Sponsors
All Listed Sponsors
collaborator

AMAG Pharmaceuticals, Inc.

INDUSTRY

lead

University of Arkansas

OTHER