An interventional study of Vaginal estrogen tablet and Via Solv Wellness (Hyaluronic Acid Therapy) in Genitourinary Syndrome of Menopause (GSM), sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Vaginal estrogen tablet · Device: Via Solv Wellness (Hyaluronic Acid Therapy)
Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks.
Drug: Vaginal 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.
The dosage of Via will be a pea-sized amount applied vaginally along the vaginal and vulvar walls nightly for 16 weeks.
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
Plan to share: Yes — 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.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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