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

NCT ID: NCT07038070

Last Updated: 2025-06-26

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Genitourinary Syndrome of Menopause (GSM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Vaginal estrogen tablet

Intervention Type 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.

Via Solv Wellness (Hyaluronic Acid Therapy)

Intervention Type 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 Alone

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

Group Type ACTIVE_COMPARATOR

Vaginal estrogen tablet

Intervention Type 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.

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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Central Contacts

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Benjamin Brucker

Role: CONTACT

917-520-1848

Nadege Assassi

Role: CONTACT

732-668-8160

Other Identifiers

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25-00415

Identifier Type: -

Identifier Source: org_study_id

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