title: Standards for Clinical Trials in Male and Female Sexual Dysfunction: IV. Unique Aspects of Clinical Trials in Female Sexual Dysfunction.
abstract: 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.
authors.affiliation: Departments of Psychology and 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: 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*; D005260:Female; D006801:Humans; D012735:Sexual Dysfunction, Physiological / Q000628:therapy*; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis / Q000628:therapy*
keywords: Clinical Trials; Female Sexual Dysfunction; Standards