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Not Yet Recruiting NCT05672901

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

Conditions: Genitourinary Syndrome of Menopause

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: Stratpharma AG

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Able to provide informed consentConfirmed postmenopausal ageDiagnosed genitourinary syndrome of menopauseAccess to a smartphone, tablet or computer, and to a functional email address.Exclusion Criteria:Contraindication for the use of estrogen therapyUnable to provide informed consentPatient unable to apply topical deviceAllergy or intolerance to ingredients or excipients of the formulation of studied products

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05672901). StuddyBuddy aggregates publicly available trial information.