Comparison of StrataMGT and Estrogen Cream for Treating Genitourinary syndrome of menopause in Women: A Non-Inferiority Study

StrataMGT for the treatment of Genitourinary Syndrome of Menopause The trial for the treatment of Genitourinary Syndrome of Menopause involves the use of a silicone-based gel known as StrataMGT, which forms a protective and hydrating membrane over the skin, aiming to reduce symptoms such as dryness, itching, burning, and discomfort during intercourse. Participants will receive informational materials including a patient information leaflet and detailed care instructions provided by the research coordinator. The intervention will be delivered by trained healthcare providers with relevant expertise, such as gynecologists or research nurses. These interactions will consist of a clinical examination of the area (around 15 minutes) and completion of a questionnaire (5-10 minutes). Study personnel will receive training by thoroughly reviewing the study protocol. No additional training will be required for vaginal examinations, as these are standard routine procedures. For product application, research coordinators will be trained using the Patient Information Leaflet (PIL). During the Site Initiation Visit, the sponsor will provide a comprehensive explanation to ensure proper application of the product. The mode of delivery will be a combination of face-to-face interactions during on-site visits and digital communication for online self-assessments. Participants will have two on-site visits (at the start and end of the study) and will complete two online self-assessments during the treatment period. The intervention will be administered individually, with participants using the gel as directed for three months. Each participant will undergo a baseline assessment, after which they will be randomly assigned to receive either the StrataMGT or the estrogen vaginal cream Ovestin. The study includes a potential wash-out month for those currently on estrogen therapy, followed by the three-month treatment period. The location for on-site assessments will be a designated medical facility, while online assessments can be completed at the participants' convenience. The intervention involves applying StrataMGT to the affected area at least twice daily for continuous contact, 24 hours a day, 7 days a week, over a period of three months. Participants should wash their hands before applying 3 to 5 drops of StrataMGT intravaginally and distribute it evenly. Additional applications are recommended after each urination, bowel movement, or wash, and the gel can be reapplied as needed throughout the day to ensure constant contact with the mucosa or skin and to reduce symptoms. No drying, rubbing, or massaging is required as the gel does not penetrate the mucosa or skin. This regimen is maintained long-term to support mucosal health The study aims to enroll 100 female patients, who will be evaluated based on treatment success with either StrataMGT or Ovestin. Participants are required to adhere to the treatment regimen, complete monthly online questionnaires, and return all study products at the end of the study. This comprehensive approach ensures the accurate assessment of the investigational product's effectiveness compared to the control product.