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NCT04544475 · ClinicalTrials.gov registry record · NA
A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
A NA study of Genitourinary Syndrome of Menopause (GSM), sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT04544475: Completed NA study of Genitourinary Syndrome of Menopause (GSM), sponsored by NYU Langone Health.
NCT04544475 is a NA study of Genitourinary Syndrome of Menopause (GSM) that has completed, run by NYU Langone Health. The registered enrollment target is 49 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04544475, a NA study of Genitourinary Syndrome of Menopause (GSM), has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The VSQ (Vulvovaginal Symptoms Questionnaire) is a 21-question survey developed in 2012 that specifically asks about GSM symptoms, their emotional impact, sexual impact, and life impact. Each question is scored from 0 (free of discomfort) to 3 (severe discomfort) The total score ranges from 0 (symptom-free in all areas) to 63 (severe discomfort in all areas) - the higher the score, the more severe the discomfort.
Conditions Studied
Interventions
- DEVICE Revaree
- DRUG Estrace
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2022-10-03 |
| Phase | NA |
What the finished NCT04544475 record still lists
NCT04544475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Genitourinary Syndrome of Menopause (GSM) appearing as the primary indexed condition, and to 2 interventions - of which Revaree is the first listed.
NCT04544475 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04544475 about?
NCT04544475 is a clinical study titled "A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause". 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...
What is the current status of trial NCT04544475?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2021-09-01. Estimated completion is 2022-10-03.
What conditions does trial NCT04544475 study?
This clinical trial studies the following conditions: Genitourinary Syndrome of Menopause (GSM).
What interventions are being tested in trial NCT04544475?
The interventions under investigation include: Revaree (DEVICE), Estrace (DRUG).
Who is sponsoring clinical trial NCT04544475?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04544475 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04544475's enrollment target sits among peer trials
49 1379th of 2000 higher than 620 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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