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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04544475
• Collaborator: JDS Therapeutics, LLC (Industry)
• Enrollment: 49
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genitourinary Syndrome of Menopause (GSM)	Device: Revaree; Drug: Estrace	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational	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.; Other Names: HLA Vaginal Insert
Active Comparator: Standard of Care	Drug: Estrace; Vaginal estrogen cream, estradiol: 100mcg; Other Names: Vaginal estrogen cream

Outcome Measures

Primary Outcome Measures

1. Change in VSQ Score [Baseline, Week 12]

   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.

Secondary Outcome Measures

1. Change in VMI [Baseline, Week 12]

   VMI (Vaginal Maturation Index) is the microscopic analysis of vaginal tissue that assigns the percentage to the amount of parabasal, intermediate, and squamous cells visualized that add up to 100%. Only the % of squamous cells will be reported in this study since that is most closely correlated with hormonal influence on the vaginal tissue. Vaginal tissue sample will be obtained via scraping for VMI.

2. Change in Vaginal pH [Baseline, Week 12]

   Pelvic samples will be collected to test vaginal pH

3. Change in VAS Score [Baseline, Week 12]

   VAS (Visual Analog Scale) score will be reported for dyspareunia, itching, and dryness. VAS is a visual scale attempting to capture the intensity of a symptom. For each symptom, the score ranges from 0-10. The higher the score, the more severe the symptom. Each symptom will be reported separately.

4. Vaginal Rugal Folds [Week 12]

   During the pelvic exam, the investigator will note the presence of vaginal rugal folds. This outcome measure is a binary variable (present or not present) and single/categorical endpoint -- it will be reported as the percentage of patients with rugal folds divided by the cohort size.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Postmenopausal status as defined by amenorrhea for >12 months or history of bilateral salpingo-oophrectomy or if the patient has had a hysterectomy and menopausal symptoms for >1 year or FSH > 40

2. Symptoms of GSM

3. Negative Pap smear as per ASCCP guidelines

4. Capable of giving informed consent

5. Ambulatory

6. Capable and willing to follow all study-relation procedures

Exclusion Criteria:

1. Use of any HRT (systemic or local) or raloxifene within six weeks of proposed start date

2. History of estrogen-sensitive tumor

3. Undiagnosed vaginal bleeding in the past 12 months

4. History of thromboembolic event

5. Currently have or have had liver problem

6. Bleeding disorder

7. Impaired mental status

8. Prior pelvic irradiation

9. Active vaginal infection

10. Any medical reason the investigator deems incompatible with treatment with vaginal estrogen

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• JDS Therapeutics, LLC

Investigators

• Principal Investigator: Lila Nachtigall, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04544475
• Other Study ID Numbers: 19-01922
• First Posted: Sep 10, 2020
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Syndrome; Estrogens; Estradiol

Study Results

No Results Posted as of Aug 16, 2022