Fisher William A, Gruenwald Ilan, Jannini Emmanuele A, Lev-Sagie Ahinoam, Lowenstein Lior, Pyke Robert E, Reisman Yakov, Revicki Dennis A, Rubio-Aurioles Eusebio
Departments of Psychology and Obstetrics and Gynaecology, Western University, London, ON, Canada.
Neurourology Unit, Rambam Medical Center, Haifa, Israel.
J Sex Med. 2017 Jan;14(1):19-26. doi: 10.1016/j.jsxm.2016.09.022.
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.
本文是该系列的第四篇文章《男性和女性性功能障碍临床试验标准》，重点关注女性性功能障碍治疗临床试验所特有的临床试验设计和测量方面。该领域的挑战包括女性性功能障碍全谱系治疗开发和临床试验研究的范围有限、监管考量不断变化、女性性功能障碍诊断标准不断变化，以及需要针对这些变化阐明评估程序。讨论聚焦于应对女性性功能障碍临床试验中这些挑战的方法。
