About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- StrataMGT
- Estrace 0.01% Vaginal Cream