Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer Study
NCT ID: NCT07038070
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
196 participants
INTERVENTIONAL
2025-07-01
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Vaginal Estrogen + Hyaluronic acid (HLA)
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 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.
Via 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.
Vaginal Estrogen Alone
Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks.
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.
Interventions
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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.
Via 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.
Eligibility Criteria
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Inclusion Criteria
* 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 using systemic hormone replacement therapy
* Subjects currently using estrogen hormonal therapies or hormone modulators (aromatase inhibitors or selective estrogen receptor modulators)
45 Years
FEMALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Benjamin Brucker
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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25-00415
Identifier Type: -
Identifier Source: org_study_id
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