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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-10-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Genitourinary Syndrome of Menopause (GSM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational

Group Type EXPERIMENTAL

Revaree

Intervention Type DEVICE

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.

Standard of Care

Group Type ACTIVE_COMPARATOR

Estrace

Intervention Type DRUG

Vaginal estrogen cream, estradiol: 100mcg

Interventions

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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.

Intervention Type DEVICE

Estrace

Vaginal estrogen cream, estradiol: 100mcg

Intervention Type DRUG

Other Intervention Names

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HLA Vaginal Insert Vaginal estrogen cream

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes