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

Genitourinary Syndrome of Menopause (GSM) Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause (GSM)
• Syndrome

• NCT number: NCT04544475
• Study type: Interventional
• Source: NYU Langone Health
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Completion date: October 3, 2022