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

  • William A. Fisher*
  • , Ilan Gruenwald
  • , Emmanuele A. Jannini
  • , Ahinoam Lev-Sagie
  • , Lior Lowenstein
  • , Robert E. Pyke
  • , Yakov Reisman
  • , Dennis A. Revicki
  • , Eusebio Rubio-Aurioles
  • *Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

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.

Original languageEnglish
Pages (from-to)3-18
Number of pages16
JournalJournal of Sexual Medicine
Volume14
Issue number1
DOIs
StatePublished - 1 Jan 2017
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2016 International Society for Sexual Medicine

Keywords

  • Clinical Trials
  • Male Sexual Dysfunction
  • Standards

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