A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause

NCT04544475•NYU Langone Health

Summary

Non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (GSM) are needed. In this proposed trial, patients who are diagnosed with GSM will be randomized to receive either a hyaluronic acid (HLA) vaginal insert or vaginal estrogen topical cream for 12 weeks. There will be a baseline visit and an 12 week follow up visit, at which points the patient will undergo a detailed history and physical examination including a pelvic exam, vaginal pH sampling, vaginal cell sample for microscopic analysis, and will fill out a vulvovaginal symptom questionnaire (VSQ). These study arms will be analyzed to assess the efficacy of HLA as compared to the gold standard of vaginal estrogen to treat GSM symptoms.

Eligibility

Age

18 - 100 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Postmenopausal status as defined by amenorrhea for \>12 months or history of bilateral salpingo-oophrectomy or if the patient has had a hysterectomy and menopausal symptoms for \>1 year or FSH \> 40
•2. Symptoms of GSM
•3. Negative Pap smear as per ASCCP guidelines
•4. Capable of giving informed consent
•5. Ambulatory
•6. Capable and willing to follow all study-relation procedures

Exclusion Criteria

•1. Use of any HRT (systemic or local) or raloxifene within six weeks of proposed start date
•2. History of estrogen-sensitive tumor
•3. Undiagnosed vaginal bleeding in the past 12 months
•4. History of thromboembolic event
•5. Currently have or have had liver problem
•6. Bleeding disorder
•7. Impaired mental status
•8. Prior pelvic irradiation
•9. Active vaginal infection
•10. Any medical reason the investigator deems incompatible with treatment with vaginal estrogen

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

September 1, 2021

Primary Completion Date

October 3, 2022

Completion Date

October 3, 2022

Last Updated

October 13, 2023

Enrollment

ACTUAL participants

Conditions

Genitourinary Syndrome of Menopause (GSM)

Interventions

Revaree

DEVICE

Estrace

DRUG

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

NCT07038070

Genitourinary Syndrome of Menopause (GSM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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