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

被引:16
作者
Fisher, William A. [1 ,2 ]
Gruenwald, Ilan [3 ]
Jannini, Emmanuele A. [4 ]
Lev-Sagie, Ahinoam [5 ]
Lowenstein, Lior [6 ]
Pyke, Robert E. [7 ]
Reisman, Yakov [8 ]
Revicki, Dennis A. [9 ]
Rubio-Aurioles, Eusebio [10 ,11 ]
机构
[1] Univ Western Ontario, Dept Psychol, London, ON N6A 5C2, Canada
[2] Univ Western Ontario, Dept Obstet & Gynaecol, London, ON N6A 5C2, Canada
[3] Rambam Med Ctr, Dept Urol, Neurourol Unit, Haifa, Israel
[4] Univ Roma Tor Vergata, Dept Syst Med, Endocrinol & Med Sexol, Rome, Italy
[5] Hadassah Hebrew Univ Med Ctr, Dept Obstet & Gynecol, Jerusalem, Israel
[6] Rambam Med Ctr, Dept Obstet & Gynecol, Haifa, Israel
[7] Pykonsult LLC, New Fairfield, CT USA
[8] Amstelland Hosp, Sexual Clin, Amstelveen, Netherlands
[9] Evidera, Outcomes Res, Bethesda, MD USA
[10] Asociac Mexicana Salud Sexual AC, Mexico City, DF, Mexico
[11] Univ Nacl Autonoma Mexico, Mexico City, DF, Mexico
关键词
Clinical Trials; Male Sexual Dysfunction; Standards; TESTOSTERONE REPLACEMENT THERAPY; AD-HOC COMMITTEE; PREMATURE-EJACULATION; ERECTILE DYSFUNCTION; PEYRONIES-DISEASE; INTERNATIONAL-SOCIETY; DESIRE DISORDER; PROSTATE-CANCER; DOUBLE-BLIND; LONG-TERM;
D O I
10.1016/j.jsxm.2016.08.016
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
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. Copyright (C) 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
引用
收藏
页码:3 / 18
页数:16
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