NCT05672901NARecruiting

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

Stratpharma AG

Start Date

4/4/2023

Completion Date

9/1/2026

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

Age Range: 18 years to No maximum

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

Interventions

DEVICE

StrataMGT

DRUG

Estrace 0.01% Vaginal Cream

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Conditions

Genitourinary Syndrome of Menopause

Locations

Orange Coast Women's Medical Group

Laguna Hills, California 92653

United States

Abba Medical Group

Miami, Florida 33176

United States

One Health Research Clinic

Johns Creek, Georgia 30097

United States