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

Recruiting now · Not applicable

Conditions studied: Genitourinary Syndrome of Menopause

In brief

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.

Key facts

Study ID

NCT05672901

Run by

Stratpharma AG

People needed

100

Starts

2023-04-04

Expected to finish

2026-09-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Orange Coast Women's Medical Group — Laguna Hills, California, United States (enrolling)
• Abba Medical Group — Miami, Florida, United States (enrolling)
• One Health Research Clinic — Johns Creek, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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