RecruitingNot Applicable

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

United States100 participantsStarted 2023-04-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PROM: Quality of Life

Timeframe: 3 months

Trial details

NCT IDNCT05672901

SponsorStratpharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Genitourinary Syndrome of Menopause trials