Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction |
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Affiliation: | 1. Department of Cardiology, Nuffield House, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham B15 2TH, UK;2. Institute of Immunology & Immunotherapy, University of Birmingham, Department of Cellular Pathology, Queen Elizabeth Hospital, Birmingham B15 2WB, UK |
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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. |
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Keywords: | Clinical Trials Male Sexual Dysfunction Standards |
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