Actively Recruiting
Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
Led by Stratpharma AG · Updated on 2026-02-20
100
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of StrataMGT, a silicone gel, compared to estrogen vaginal cream in managing Genitourinary Syndrome of Menopause (GSM). The main goal is to see if StrataMGT is not worse than standard estrogen treatment in improving quality of life for women experiencing GSM. This is a randomized controlled trial sponsored by Stratpharma AG. Participants will be randomly assigned to one of two groups. One group will use StrataMGT, applying the silicone gel 2 to 5 times daily without a limit on application frequency, for three consecutive months. The other group will use Estrace vaginal cream, starting with 1 gram daily for two weeks, then switching to a maintenance dose of 1 gram three times a week for the same duration. These treatments are being studied to compare their effects on symptoms and quality of life. During the study, participants will be assessed monthly for three months. Researchers will monitor quality of life, clinical signs, symptoms, visual pathology, and any adverse reactions. Patient-reported outcome measures including symptoms, dyspareunia, product rating, and treatment adherence will also be collected. These evaluations will help determine how each treatment affects the participants over the study period.
CONDITIONS
Brief 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants apply either StrataMGT silicone gel or Estrace vaginal cream to manage genitourinary syndrome of menopause.
Regular visits as scheduled during treatment
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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