Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544475
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2020-09-04
Brief Title:
A Randomized Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Randomized Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None