Fisher William A, Gruenwald Ilan, Jannini Emmanuele A, Lev-Sagie Ahinoam, Lowenstein Lior, Pyke Robert E, Reisman Yakov, Revicki Dennis A, Rubio-Aurioles Eusebio
Department of Psychology and Department of Obstetrics and Gynaecology, Western University, London, ON, Canada.
Department of Urology, Director, Neurourology Unit, Rambam Medical Center, Haifa, Israel.
J Sex Med. 2017 Jan;14(1):3-18. doi: 10.1016/j.jsxm.2016.08.016.
This series of articles, Standards for Clinical Trials in Male and Female Sexual Dysfunction, began with the discussion of a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for the selection of study population and study duration in male and female sexual dysfunction. The second article in this series discussed fundamental principles in development, validation, and selection of patient- (and partner-) reported outcome assessment. The third and present article in this series discusses selected aspects of sexual dysfunction that are that are unique to male sexual dysfunctions and relevant to the conduct of clinical trials of candidate treatments for men.
这一系列文章《男性和女性性功能障碍临床试验标准》开篇讨论了男性和女性性功能障碍临床试验设计的通用预期标准、I期至IV期临床试验设计的共同基本原理，以及男性和女性性功能障碍研究人群选择和研究持续时间的共同考量因素。本系列的第二篇文章讨论了患者（及伴侣）报告结局评估的开发、验证和选择的基本原则。本系列的第三篇即本文讨论了男性性功能障碍特有的、与男性候选治疗药物临床试验实施相关的性功能障碍的特定方面。
