Hyaluronic Acid Therapy for Genitourinary Syndrome

Overseen By Benjamin Brucker

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Systemic hormones, Estrogen therapies

Disqualifiers: Hormone-sensitive disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding Via, a hyaluronic acid-based vaginal moisturizer, to vaginal estrogen treatment can better relieve symptoms of genitourinary syndrome of menopause (GSM) than using estrogen alone. GSM can cause discomfort such as dryness, itching, and urinary issues. Women who have been postmenopausal for at least a year and are experiencing GSM symptoms, but haven't used vaginal estrogen or hyaluronic acid for these symptoms in the last three months, might be suitable candidates. Participants will use either vaginal estrogen alone or a combination of estrogen and the moisturizer to determine which is more effective. As an unphased trial, this study provides a unique opportunity to explore new treatment combinations for GSM symptoms.

Will I have to stop taking my current medications?

If you are currently using systemic hormone replacement therapy or estrogen hormonal therapies, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hyaluronic acid is generally safe for treating menopause symptoms affecting the urinary and genital areas. In one study comparing vaginal hyaluronic acid to standard vaginal estrogen, over 90% of participants experienced improvement, and no serious side effects related to the treatment occurred. This suggests that the treatment is well-tolerated and could be a promising non-hormonal option for those seeking relief from these symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for genitourinary syndrome, which typically rely solely on vaginal estrogen to alleviate symptoms, the new approach combines estrogen with hyaluronic acid. Researchers are excited about this treatment because hyaluronic acid is known for its moisturizing and healing properties, potentially enhancing the effectiveness of estrogen by improving tissue hydration and elasticity. This dual approach not only aims to address symptoms more comprehensively but also holds promise for quicker and more sustained relief, offering a fresh perspective on managing this condition.

What evidence suggests that this trial's treatments could be effective for genitourinary syndrome of menopause?

Research has shown that hyaluronic acid effectively reduces symptoms like dryness and discomfort in the vaginal area. In some cases, just one injection of hyaluronic acid improved symptoms for up to a year. Via, a specific vaginal moisturizer made with hyaluronic acid, has received FDA approval for safety and effectiveness. It is designed to restore the natural moisture of the vaginal area. In this trial, one group of participants will use vaginal estrogen alone, while another group will use a combination of vaginal estrogen and Via (hyaluronic acid). When combined with vaginal estrogen, it is expected to provide even better relief from symptoms of genitourinary syndrome than using estrogen alone. ^{1 6 7 8 9}

Who Is on the Research Team?

Benjamin Brucker

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for women experiencing genitourinary syndrome, often related to menopause. Participants should be seeking treatment for symptoms like vaginal dryness or discomfort. The study excludes those who have used other treatments recently, have certain health conditions affecting the vagina or urinary tract, or are allergic to the products being tested.

Inclusion Criteria

I can understand and sign the consent form.

I can attend all required study visits.

I have never used vaginal estrogen for GSM, or haven't used it or hyaluronic acid in the last 3 months.

Exclusion Criteria

I am currently on hormone replacement therapy.

I am currently being treated for a hormone-sensitive cancer.

I am currently using estrogen hormonal therapies or hormone modulators.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. In the experimental group, participants also apply Via (Hyaluronic acid) nightly for 16 weeks.

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal estrogen tablet
• Via Solv Wellness

Trial Overview The study tests if using Via (a hyaluronic acid-based moisturizer) with a vaginal estrogen tablet provides better relief from menopausal symptoms than just the estrogen tablet alone. It's designed to compare these two approaches in women with genitourinary syndrome.

How Is the Trial Designed?

Group I: Vaginal Estrogen + Hyaluronic acid (HLA) Experimental Treatment 2 Interventions

Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Participants will concomitantly apply Via (Hyaluronic acid) nightly for 16 weeks.

Group II: Vaginal Estrogen Alone Active Control 1 Intervention

Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07038070

Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer ... This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40773978/

Hyaluronic acid injection to treat symptoms of vulvovaginal ... Conclusions: A single injection session of hyaluronic acid is effective in reducing vulvovaginal symptomatology and in improving sexual function for up to 52 ...

3. hcp.solvwellness.com hcp.solvwellness.com/wp-content/uploads/2022/03/22-0202_11x8.5_trifold_factsheet-Via-FINAL.pdf

when art & science come together. Via Vaginal Moisturizer is a 510(k) medical device, FDA-cleared for safety and efficacy (Reg. # K201922). Via is a water-based moisturizer that can be used ...

4. solvwellness.com solvwellness.com/products/via-vaginal-dryness?srsltid=AfmBOorVZ-uxqrDaHuW9yiYjffRLCwZullEhxthZiiyzGH6Wo_AVFEKJ

via vaginal moisturizer This non-hormonal vaginal moisturizer is specifically designed with an advanced formula to replenish the vagina's naturally occurring supply of moisture.

5. ajog.org ajog.org/article/S0002-9378(16)30518-X/fulltext

Genitourinary syndrome of menopause: an overview ... Pilot studies have found that vaginal erbium laser treatment significantly improves both vaginal dryness and dyspareunia up to 24 weeks after treatment. 42.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39042017/

A randomized, pilot trial comparing vaginal hyaluronic acid ... The aim of this study was to compare the efficacy of a non-hormone alternative, vaginal hyaluronic acid (HLA), to a standard-of-care therapy, vaginal estrogen.

7. withpower.com withpower.com/trial/phase-genitourinary-syndrome-of-menopause-gsm-6-2025-ef3f4

Hyaluronic Acid Therapy for Genitourinary Syndrome This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11469619/

A randomized, pilot trial comparing vaginal hyaluronic acid ... Vaginal hyaluronic acid may be a promising non-hormonal therapy for genitourinary syndrome of menopause. Key Words: Estrogen effects, Female urogenital diseases ...

9. scholars.uthscsa.edu scholars.uthscsa.edu/en/publications/a-randomized-pilot-trial-comparing-vaginal-hyaluronic-acid-to-vag

A randomized, pilot trial comparing vaginal hyaluronic acid ... Over 90% participants noted improvement on the PGI-I in both groups (P = 0.61). No treatment-related serious adverse events occurred.