title: Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.
abstract: This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present 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 selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical trial design for women.
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*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D012725:Sexual Behavior; D012735:Sexual Dysfunction, Physiological / Q000628:therapy*; D020018:Sexual Dysfunctions, Psychological / Q000628:therapy*
keywords: Clinical Trials; Female Sexual Dysfunction; Male Sexual Dysfunction