MREC Reviewer Comment
Protocol Title
A Prospective Clinical Study to Evaluate the Therapeutic Efficacy and Clinical Safety of Strogenzo in the Management of Perimenopausal and Menopausal Symptoms
Completely satisfied and informative data
Needs Explanation
Comments to the applicant
Same as for the committee
Comment to the Committee
1-Preferable to edit Arabic title
2-Explain how to assess hypersensitivity to any of the components of the drug in recruitment exclusion criteria
3-Is there any grouping for pre and post menopausal participants ?
4- Informed consent is not signed
5- Potential side effects need more clarification in the informed consent
Informed consent form:
Needs Modification
