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

NCT07038070 | Withdrawn FDA Device

• 1 other identifier: 25-00415
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause (GSM)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percent change in vaginal pH

  Baseline, Week 16

• Change in vaginal maturation index (VMI)

  Baseline, Week 16

• Number of adverse events related to treatment

  Week 16

Study Arms (2)

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.

Drug: Vaginal estrogen tablet; Device: Via Solv Wellness (Hyaluronic Acid Therapy)

Vaginal Estrogen Alone

ACTIVE COMPARATOR

Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks.

Drug: Vaginal estrogen tablet

Interventions

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.

Vaginal Estrogen + Hyaluronic acid (HLA); Vaginal Estrogen Alone

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.

Vaginal Estrogen + Hyaluronic acid (HLA)

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Benjamin Brucker

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: 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.

Locations

US (1)