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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544475
• Other study ID #: 19-01922
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 3, 2022

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause (GSM)
• Syndrome

Intervention

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.

Drug:
• Estrace
Vaginal estrogen cream, estradiol: 100mcg

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	JDS Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VSQ Score	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.	Baseline, Week 12
Secondary	Change in VMI	VMI (Vaginal Maturation Index) is the microscopic analysis of vaginal tissue that assigns the percentage to the amount of squamous cells visualized. 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.	Baseline, Week 12
Secondary	Change in Vaginal pH	Pelvic samples will be collected to test vaginal pH.	Baseline, Week 12
Secondary	Change in VAS Score - Dyspareunia	VAS (Visual Analog Scale) score will be reported for dyspareunia. 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.	Baseline, Week 12