Comparing silicone gel and estrogen cream for menopause-related symptoms
Official title: Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
Run by Stratpharma AG · NCT05672901 · Data updated 2026-11-12
This study is testing if a new silicone gel can help women with menopause-related symptoms just as well as the usual estrogen cream.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Stratpharma AG Industry-sponsored |
| Locations | 3 sites (Laguna Hills, California and 2 other locations) |
| Status | Recruiting |
| Started | April 4, 2023 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT05672901 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include postmenopausal women diagnosed with genitourinary syndrome of menopause who can provide informed consent.
✕Probably not a fit
Patients with contraindications to estrogen therapy or those unable to apply topical treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of StrataMGT, a silicone gel, in managing Genitourinary Syndrome of Menopause (GSM) compared to traditional estrogen vaginal cream. Participants will be randomly assigned to receive either treatment for three months, during which their quality of life, clinical signs, symptoms, and any adverse reactions will be monitored monthly. The primary objective is to determine if StrataMGT is non-inferior to estrogen therapy in improving patient outcomes.
Why it matters
Potential benefit: If successful, this study could provide a non-hormonal alternative for managing GSM, benefiting patients who prefer to avoid estrogen therapy.
How similar studies have gone: While there have been studies on estrogen therapy for GSM, the use of silicone gel as an alternative is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide informed consent * Confirmed postmenopausal age * Diagnosed genitourinary syndrome of menopause * Access to a smartphone, tablet or computer, and to a functional email address. Exclusion Criteria: * Contraindication for the use of estrogen therapy * Unable to provide informed consent * Patient unable to apply topical device * Allergy or intolerance to ingredients or excipients of the formulation of studied products
Where it's running
-
Orange Coast Women's Medical Group
Laguna Hills, California, United States Recruiting -
Abba Medical Group
Miami, Florida, United States Recruiting -
One Health Research Clinic
Johns Creek, Georgia, United States Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.