Silicone Gel vs. Estrogen Cream for Genitourinary Syndrome of Menopause
This study is comparing two treatments for Genitourinary Syndrome of Menopause (GSM), a condition that can cause vaginal dryness, itching, and pain. You would receive either StrataMGT, a silicone gel, or Estrace 0.01% Vaginal Cream, an estrogen cream. The main goal is to see if StrataMGT is as effective as the standard estrogen cream in improving your quality of life over three months. To join, you must be a postmenopausal woman, at least 18 years old, diagnosed with GSM, and have access to a smartphone or computer. You cannot participate if you have a medical reason not to use estrogen therapy or cannot apply topical treatments.
- Study design
- This is an interventional, randomized controlled trial planning to enroll 100 women. Participants will be assigned to one of two treatment groups.
- What's involved
- You would use either StrataMGT or Estrace 0.01% Vaginal Cream for three consecutive months. After an initial assessment, you will have monthly assessments for quality of life, symptoms, and any side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life will be assessed at 3 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
At a glance
Conditions
NCT05672901
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Abba Medical Group
Miami, Floridastudy coordinator listed
Recruiting
One Health Research Clinic
Johns Creek, Georgiastudy coordinator listed
Recruiting
Orange Coast Women's Medical Group
Laguna Hills, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- PROM: Quality of Life3 months
The improvement of patient quality of life will be assessed at baseline and during each monthly follow-up using the patient-rated Vulvar Disease Quality of Life (VQLI) Index questionnaire. Questions are rated on a numeric scale from 0 (not at all) - 3 (very much). This outcome is patient-rated, thus unblinded.