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The study was placed on hold by the Sponsor for ~1 year. Given the prolonged hold and absence of participant activity, the study was closed.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Estrogen + Hyaluronic acid (HLA) | Experimental | Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Participants will concomitantly apply Via (Hyaluronic acid) nightly for 16 weeks. |
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| Vaginal Estrogen Alone | Active Comparator | Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal estrogen tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in vaginal pH | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Brucker | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to benajmin.brucker@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to benajmin.brucker@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| Via Solv Wellness (Hyaluronic Acid Therapy) | Device | The dosage of Via will be a pea-sized amount applied vaginally along the vaginal and vulvar walls nightly for 16 weeks. |
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| Baseline, Week 16 |
| Number of adverse events related to treatment | Week 16 |