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Clinical trial

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

ID
Name
19-01922
Description
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.
Trial arms
Trial start
2021-09-01
Estimated PCD
2022-10-03
Trial end
2022-10-03
Status
Completed
Treatment
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.
Arms:
Investigational
Other names:
HLA Vaginal Insert
Estrace
Vaginal estrogen cream, estradiol: 100mcg
Arms:
Standard of Care
Other names:
Vaginal estrogen cream
Size
49
Primary endpoint
Change in VSQ Score
Baseline, Week 12
Eligibility 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 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}
Updated at
2023-10-13

1 organization

1 product

1 indication

Organization
NYU Langone Health
Product
Estrace
Indication
Genitourinary Syndrome of Menopause