Overview

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

Status:
Not yet recruiting
Trial end date:
2022-06-30
Target enrollment:
0
Participant gender:
Female
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 8 weeks. There will be a baseline visit and an 8 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NYU Langone Health
Collaborator:
JDS Therapeutics, LLC
Treatments:
Estradiol
Estrogens
Criteria
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 within two years

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