Comparing silicone gel and estrogen cream for menopause-related symptoms
Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stratpharma AG Industry-sponsored |
| Locations | 3 sites (Laguna Hills, California and 2 other locations) |
| Trial ID | NCT05672901 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal women diagnosed with genitourinary syndrome of menopause who can provide informed consent.
Not a fit: Patients with contraindications to estrogen therapy or those unable to apply topical treatments may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Laguna Hills, California and 2 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.