Genitourinary Syndrome of Menopause (GSM)
Conditions
Brief summary
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.
Interventions
DRUGVaginal estrogen tablet
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.
DEVICEVia Solv Wellness (Hyaluronic Acid Therapy)
The dosage of Via will be a pea-sized amount applied vaginally along the vaginal and vulvar walls nightly for 16 weeks.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal (last menstrual period at least 12 months ago). * Aged 45 years or older and have symptoms of Genitourinary Syndrome of Menopause (GSM). * Have never tried vaginal estrogen therapy, or have tried vaginal estrogen therapy, but have not used vaginal estrogen and/or hyaluronic acid products for management of GSM symptoms within the last 3 months. * Capable of signing informed consent. * Capable and willing to follow all study-relation visits.
Exclusion criteria
* Subjects currently diagnosed with or undergoing treatment for hormone-sensitive disease (e.g. breast cancer) * Subjects currently using systemic hormone replacement therapy * Subjects currently using estrogen hormonal therapies or hormone modulators (aromatase inhibitors or selective estrogen receptor modulators)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in vulvovaginal symptom questionnaire (VSQ) score | Baseline, Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in vaginal pH | Baseline, Week 16 | — |
| Change in vaginal maturation index (VMI) | Baseline, Week 16 | 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. |
| Number of adverse events related to treatment | Week 16 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Brucker
NYU Langone Health
Outcome results
None listed