This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief from symptoms of genitourinary syndrome of menopause (GSM) in the urogynecologic patient population, compared to administration of vaginal estrogen alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
196
The dosage of the vaginal estrogen will be one 10mcg tablet administered vaginally nightly for 2 weeks, then administered vaginally twice weekly for 14 weeks.
The dosage of Via will be a pea-sized amount applied vaginally along the vaginal and vulvar walls nightly for 16 weeks.
NYU Langone Health
New York, New York, United States
Percent change in vulvovaginal symptom questionnaire (VSQ) score
The VSQ is a 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
Time frame: Baseline, Week 16
Percent change in vaginal pH
Time frame: Baseline, Week 16
Change in vaginal maturation index (VMI)
The number of parabasal cells, intermediate cells, and superficial cells will be counted, and the maturation index will be calculated as the percent basal cells visualized.
Time frame: Baseline, Week 16
Number of adverse events related to treatment
Time frame: Week 16
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