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

NCT04544475 | Completed Results FDA Device

• 1 other identifier: 19-01922
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause (GSM)

Outcome Measures

Primary Outcomes (1)

• Change in VSQ Score

  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.

  Baseline, Week 12

Secondary Outcomes (3)

• Change in VMI

  Baseline, Week 12

• Change in Vaginal pH

  Baseline, Week 12

• Change in VAS Score - Dyspareunia

  Baseline, Week 12

Study Arms (2)

Investigational

EXPERIMENTAL

Device: Revaree

Standard of Care

ACTIVE COMPARATOR

Drug: Estrace

Interventions

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.

Also known as: HLA Vaginal Insert

Investigational

Estrace DRUG

Vaginal estrogen cream, estradiol: 100mcg

Also known as: Vaginal estrogen cream

Standard of Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• JDS Therapeutics, LLC: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Agrawal S, LaPier Z, Nagpal S, Oot A, Friedman S, Hade EM, Nachtigall L, Brucker BM, Escobar C. A randomized, pilot trial comparing vaginal hyaluronic acid to vaginal estrogen for the treatment of genitourinary syndrome of menopause. Menopause. 2024 Sep 1;31(9):750-755. doi: 10.1097/GME.0000000000002390. Epub 2024 Jul 20.

  PMID: 39042017 DERIVED

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Lila Nachtigall
• Organization: NYU Langone Health

Lila.Nachtigall@nyulangone.org

2122636361

Study Officials

• Lila Nachtigall, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: October 13, 2023
• Results First Posted: October 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Surbhi.agrawal@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)