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

Overseen By Christina Escobar, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: HRT, Raloxifene

Disqualifiers: Estrogen-sensitive tumor, Vaginal bleeding, Thromboembolic event, Liver problem, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

49 Participants Needed

Trial Summary

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.

How does the drug Estrace, Revaree differ from other treatments?

Estrace, which contains estradiol, is a form of hormone replacement therapy (HRT) that helps alleviate menopausal symptoms and prevent bone loss, while Revaree is a non-hormonal vaginal insert that provides moisture and relief from vaginal dryness. This combination offers both hormonal and non-hormonal options for managing symptoms, which can be beneficial for women who cannot or prefer not to use systemic hormones. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing two treatments for women with symptoms related to menopause: a hyaluronic acid insert and an estrogen cream. The hyaluronic acid adds moisture to the vagina, while the estrogen cream restores hormone levels to keep the tissue healthy. Vaginal estrogen products have been shown to be effective and safe for treating symptoms related to menopause with few side effects.

Research Team

Lila Nachtigall, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

Negative Pap smear as per ASCCP guidelines

Capable of giving informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either a hyaluronic acid vaginal insert or vaginal estrogen topical cream for 12 weeks

12 weeks

Baseline visit, 12-week follow-up visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Estrace
• Revaree

Participant Groups

Group I: Investigational Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

JDS Therapeutics, LLC

Industry Sponsor

Trials

1

Recruited

50+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of hormone therapy and calcitriol on serum lipid profile in postmenopausal older women: association with estrogen receptor-α genotypes. [2022]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

[Clinical study of a triphasic contraceptive preparation (Norgestimate 180/215/250 micrograms + ethinylestradiol 35 micrograms) in a population of Czech women]. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

A novel oestradiol--desogestrel preparation for hormone replacement therapy: effects on hormones, lipids, bone, climacteric symptoms and endometrium. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[The combined effect of an ethinylestradiol/desogestrel contraceptive combination on blood lipids and parameters of liver function and coagulation]. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Estradiol/nomegestrol acetate as a first-line and rescue therapy for the treatment of ovarian and deep infiltrating endometriosis. [2022]