NCT04544475

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Genitourinary Syndrome of Menopause (GSM)

Interventions

Type	Name	Description
DEVICE	Revaree	Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.
DRUG	Estrace	Vaginal estrogen cream, estradiol: 100mcg

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2020-09-10
• Last updated: 2023-10-13
• Results posted: 2023-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study