Actively Recruiting
Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
Led by Stratpharma AG · Updated on 2026-02-20
100
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is: \- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care? Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.
CONDITIONS
Official Title
Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Orange Coast Women's Medical Group
Laguna Hills, California, United States, 92653
Actively Recruiting
2
Abba Medical Group
Miami, Florida, United States, 33176
Actively Recruiting
3
One Health Research Clinic
Johns Creek, Georgia, United States, 30097
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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