title: Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction.
abstract: 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.
authors.affiliation: Department of Psychology and Department of Obstetrics and Gynaecology, Western University, London, ON, Canada. Electronic address: fisher@uwo.ca.
authors.forename: William A
authors.initials: WA
authors.lastname: Fisher
authors.affiliation: Department of Urology, Director, Neurourology Unit, Rambam Medical Center, Haifa, Israel.
authors.forename: Ilan
authors.initials: I
authors.lastname: Gruenwald
authors.affiliation: Endocrinology and Medical Sexology, Department of Systems Medicine, University of Rome, Tor Vergata, Italy.
authors.forename: Emmanuele A
authors.initials: EA
authors.lastname: Jannini
authors.affiliation: Department of Obstetrics and Gynecology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: Ahinoam
authors.initials: A
authors.lastname: Lev-Sagie
authors.affiliation: Department of Obstetrics and Gynecology, Rambam Medical Center, Haifa, Israel.
authors.forename: Lior
authors.initials: L
authors.lastname: Lowenstein
authors.affiliation: Pykonsult, LLC, New Fairfield, CT, USA.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Pyke
authors.affiliation: Medical Director Sexuality Clinics, Amstelland Hospital, Amstelveen, The Netherlands.
authors.forename: Yakov
authors.initials: Y
authors.lastname: Reisman
authors.affiliation: Outcomes Research, Evidera, Bethesda, MD, USA.
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.affiliation: Asociación Mexicana para la Salud Sexual, AC, and Universidad Nacional Autónoma de México, Mexico City, Mexico.
authors.forename: Eusebio
authors.initials: E
authors.lastname: Rubio-Aurioles
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D012735:Sexual Dysfunction, Physiological / Q000628:therapy*; D020018:Sexual Dysfunctions, Psychological / Q000628:therapy*
keywords: Clinical Trials; Male Sexual Dysfunction; Standards