Standards for Clinical Trials in Male and Female Sexual Dysfunction: IV. Unique Aspects of Clinical Trials in Female 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 ; Female 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：19-26
• 全文大小：220 K
• 卷排序：14

文摘

The focus of this article, the fourth in the series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, is on aspects of clinical trial design and measurement that are specific to clinical trials for treatments of female sexual dysfunction. Challenges in this area include the limited extent of treatment development and clinical trial research across the spectrum of female sexual dysfunctions, changing regulatory considerations, changing diagnostic criteria for female sexual dysfunction, and the need to articulate assessment procedures to these changes. Discussion focuses on approaches to addressing these challenges in clinical trials in female sexual dysfunction.