Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction

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• 作者：William A. Fisher ; PhD ; FCAHS¹ ; ^&lowast ; ; ^{fisher@uwo.ca} ; Ilan Gruenwald ; MD² ; ^&dagger ; ; Emmanuele A. Jannini ; MD³ ; ^&dagger ; ; Ahinoam Lev-Sagie ; MD⁴ ; ^&dagger ; ; Lior Lowenstein ; MD ; MHA⁵ ; ^&dagger ; ; Robert E. Pyke ; MD ; PhD⁶ ; ^&dagger ; ; Yakov Reisman ; MD ; PhD ; FECSM⁷ ; Dennis A. Revicki ; PhD⁸ ; ^&dagger ; ; Eusebio Rubio-Aurioles ; MD ; PhD⁹ ; ^&dagger ;
• 关键词：Clinical Trials ; Male Sexual Dysfunction ; Standards
• 刊名：The Journal of Sexual Medicine
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：14
• 期：1
• 页码：3-18
• 全文大小：366 K
• 卷排序：14

文摘

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.