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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stratpharma AG
• Treatments: Estradiol

Criteria

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