Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer Study

Not Applicable

Not yet recruiting

• Conditions: Genitourinary Syndrome of Menopause (GSM)
• Interventions: Drug: Vaginal estrogen tablet; Device: Via Solv Wellness (Hyaluronic Acid Therapy)

• Registration Number: NCT07038070
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 196

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Estrogen + Hyaluronic acid (HLA)	Vaginal estrogen tablet	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.
Vaginal Estrogen + Hyaluronic acid (HLA)	Via Solv Wellness (Hyaluronic Acid Therapy)	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.
Vaginal Estrogen Alone	Vaginal estrogen tablet	Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Percent change in vaginal pH	Baseline, Week 16
Number of adverse events related to treatment	Week 16

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States