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

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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
Symptoms of GSM
Negative Pap smear as per ASCCP guidelines
Capable of giving informed consent
Ambulatory
Capable and willing to follow all study-relation procedures

Exclusion Criteria

Use of any HRT (systemic or local) or raloxifene within six weeks of proposed start date
History of estrogen-sensitive tumor
Undiagnosed vaginal bleeding in the past 12 months
History of thromboembolic event
Currently have or have had liver problem
Bleeding disorder
Impaired mental status
Prior pelvic irradiation
Active vaginal infection
Any medical reason the investigator deems incompatible with treatment with vaginal estrogen

Arm && Interventions

Group	Intervention	Description
Standard of Care	Estrace	-
Investigational	Revaree	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Vaginal pH	Baseline, Week 12	Pelvic samples will be collected to test vaginal pH.
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 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.
Change in VAS Score - Dyspareunia	Baseline, Week 12	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.