Clinical trial designs for premature ejaculation: Observational, intervention and intervention preference studies

Abstract

Ideal premature ejaculation (PE) clinical trial (CT) design involves defining the population with the ISSM definition for PE, a cohort or case-control observational design, or a double-blind, placebo-controlled randomized CT design, and the use of sensitive, validated and reproducible outcome measures including stop-watched measured Intra-vaginal Ejaculatory Latency-Time and Patient Related Outcomes measured with the premature Ejaculation Profile, the Index of PE, and in drug CTs the Clinical Impression of Change. Partner Reported Outcome (PaROs) measures are also strongly recommended. This chapter reviews the methodology used in the first large CTs conducted in men with PE and the latest recommendations proposed for such CTs.