Psychometric validation of a sexual quality of life questionnaire for use in men with premature ejaculation or erectile dysfunction.

Introduction: An instrument that can systematically capture the impact of sexual dysfunction on quality of life (QoL) in men is needed.

Aims: To psychometrically validate a sexual QoL instrument for men (SQOL-M) with premature ejaculation (PE) or erectile dysfunction (ED).

Methods: The main assessment populations were men participating in clinical trials of treatments for PE or ED.

Implementation of a Bayesian adaptive design in a proof of concept study.

With increased costs of drug development the need for efficient studies has become critical. A key decision point on the development pathway has become the proof of concept study. These studies must provide clear information to the project teams to enable decision making about further developing a drug candidate but also to gain evidence that any effect size is sufficient to warrant this development given the current market environment.