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Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause

RecruitingNAAges 18 Years - anyFemaleStratpharma AG
NCT05672901 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • StrataMGT
  • Estrace 0.01% Vaginal Cream
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Where

3 sites
Orange Coast Women's Medical Group
Laguna Hills, United States
Abba Medical Group
Miami, United States
One Health Research Clinic
Johns Creek, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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