N/A
Completed N=49
A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
Genitourinary Syndrome of Menopause (GSM)
Source: ClinicalTrials.gov NCT04544475 ↗
Enrolled (actual)
49
Serious AEs
2.2%
Results posted
Oct 2023
Primary outcomePrimary: Change in VSQ Score — -3.3; -3.7 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in VSQ Score |
-3.3; -3.7 | — |
| SECONDARY Change in VMI |
4.4; 38.4 | — |
| SECONDARY Change in Vaginal pH |
-0.2; -0.3 | — |
| SECONDARY Change in VAS Score - Dyspareunia |
-3; -3.6 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT04544475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.