Standards for clinical trials in sexual dysfunctions of women: Research designs and outcomes assessment

Introduction. Clinical trials on sexual dysfunctions in women are limited in spite of the fact that sexual dysfunctions are likely more common in women than in men. Currently there are no medications approved for treatment in women, and limited data on drug efficacy or psychological efficacy in well-controlled studies. Aim. To provide recommendations/guidelines concerning state-of-the-art knowledge for the research design and outcome assessment standards for clinical trials in women's sexual dysfunctions. Methods. An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Standards for Clinical Trials in Women's Sexual Dysfunctions Committee, there were seven experts from two countries. Main Outcome Measure. Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. Results. A comprehensive update was created which included references and recommended guidelines for rationale and design of clinical trials, study populations, outcome assessments, protocol design and implementation, data analysis and reporting, as well as ethical and clinical issues related to sexual dysfunction research. Conclusions. There is a need for more research in developing standards to be used when performing clinical trials and outcomes assessment research in sexual dysfunctions of women.