A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes

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Conditions studied: Vaginal Atrophy, Genitourinary System; Disorder, Female, Vaginal Abnormality, Sexual Dysfunction, Sexual Problem

In brief

The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.

Key facts

Study ID

NCT03547089

Run by

W. Grant Stevens, MD

People needed

10

Starts

2018-08-01

Expected to finish

2020-03-01

Last updated by the study team

2019-03-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Cognitive impairment
• Women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention
• Women with active breast cancer disease
• Women currently on hormone therapy or who are pregnant
• Women who have had vaginal or pelvic surgery involving the genitalia

Where it is running

• Marina Plastic Surgery Associates — Marina del Rey, California, United States

Full record on ClinicalTrials.gov

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