Clinical Trial Methodology in Premature Ejaculation Observational, Interventional, and Treatment Preference Studies-Part II-Study Design, Outcome Measures, Data Analysis, and Reporting

Data from PE observational, interventional, and preference studies are only reliable, interpretable, and capable of being generalized to patients with PE when derived from well‐designed observational studies or intervention RCTs using ELT and subject/partner‐reported outcome measures of perceived ejaculatory control and personal/partner/relationship distress are used as trial outcome measures. McMahon CG. Clinical trial methodology in premature ejaculation observational, interventional, and treatment preference studies-Part II-Study design, outcome measures, data analysis, and reporting. J Sex Med 2008;5:1817-1833.