Hyaluronic Acid + Vaginal Estrogen for Genitourinary Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatment options for genitourinary syndrome of menopause (GSM), which causes symptoms like vaginal dryness and discomfort. Participants will receive either a hyaluronic acid (HLA) vaginal insert (Revaree) or a vaginal estrogen cream (Estrace) to determine which is more effective. The trial seeks postmenopausal women experiencing GSM symptoms who can attend two appointments over 12 weeks. The study aims to identify effective non-hormonal treatments for those who prefer or require alternatives to traditional hormone therapy. As an unphased study, this trial allows participants to contribute to important research that may lead to new treatment options for GSM.
Will I have to stop taking my current medications?
The trial requires that you stop using any hormone replacement therapy (HRT) or raloxifene at least six weeks before starting. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Revaree, which contains hyaluronic acid, is generally safe and well-tolerated. It effectively relieves symptoms like vaginal dryness without causing harmful side effects, making it a promising non-hormonal option for treating genitourinary syndrome of menopause (GSM).
In contrast, Estrace, a vaginal cream with estrogen, is widely used and approved by the FDA. However, it can cause side effects such as nausea, high blood pressure, and an increased risk of certain cancers. Users should consider these potential risks.
Both treatments have undergone safety testing, but they present different risk profiles. Participants considering these treatments should consult a healthcare provider to determine the best option for them.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for genitourinary syndrome of menopause, which typically involves hormonal treatments like vaginal estrogen (Estrace), the investigational treatment, Revaree, offers a hormone-free alternative by using hyaluronic acid. Hyaluronic acid is unique because it naturally attracts and retains moisture, which can help alleviate dryness and discomfort without the need for hormones. This is particularly exciting for individuals who cannot or prefer not to use hormonal therapies due to personal or medical reasons. Researchers are eager to see how Revaree compares to traditional treatments in terms of effectiveness and patient preference.
What evidence suggests that this trial's treatments could be effective for GSM?
Research has shown that Revaree, a vaginal insert with hyaluronic acid, effectively treats symptoms of menopause-related changes, such as vaginal dryness. Studies found that about 80% of women using Revaree experienced reduced vaginal dryness within four weeks. Another study reported an 84% improvement in dryness and an 86% reduction in discomfort. In this trial, some participants will receive Revaree as part of the investigational arm, indicating it is a promising non-hormonal option for these symptoms.678910
Who Is on the Research Team?
Lila Nachtigall, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either a hyaluronic acid vaginal insert or vaginal estrogen topical cream for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Estrace
- Revaree
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
JDS Therapeutics, LLC
Industry Sponsor