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Estrogen
A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
N/A
Waitlist Available
Led By Lila Nachtigall, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two treatments for women with symptoms related to menopause: a hyaluronic acid insert and an estrogen cream. The hyaluronic acid adds moisture to the vagina, while the estrogen cream restores hormone levels to keep the tissue healthy. Vaginal estrogen products have been shown to be effective and safe for treating symptoms related to menopause with few side effects.
Eligible Conditions
- Genitourinary Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in VSQ Score
Secondary study objectives
Change in VAS Score - Dyspareunia
Change in VMI
Change in Vaginal pH
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigationalExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Revaree
2021
N/A
~50
Find a Location
Who is running the clinical trial?
JDS Therapeutics, LLCIndustry Sponsor
NYU Langone HealthLead Sponsor
1,413 Previous Clinical Trials
855,701 Total Patients Enrolled
Lila Nachtigall, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
44 Total Patients Enrolled