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

NYU Langone Health

Status: Completed

Conditions: Genitourinary Syndrome of Menopause (GSM)

Treatments: Drug: Estrace; Device: Revaree

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04544475

19-01922

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Investigational

Experimental group

Treatment:

Device: Revaree

Standard of Care

Active Comparator group

Treatment:

Drug: Estrace