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OpenTrials
Completed

NCT Number: NCT04544475

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

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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Key information

Conditions

Genitourinary Syndrome of Menopause (GSM)

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revaree

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.

Other names: HLA Vaginal Insert

Estrace

Drug

Vaginal estrogen cream, estradiol: 100mcg

Other names: Vaginal estrogen cream

Primary outcomes

  1. Change in VSQ Score

    Time frame: 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 outcomes

  1. Change in VMI

    Time frame: 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.

  2. Change in Vaginal pH

    Time frame: Baseline, Week 12

    Pelvic samples will be collected to test vaginal pH.

  3. Change in VAS Score - Dyspareunia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • JDS Therapeutics, LLC

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2020
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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