title: Regulatory and scientific issues in studies to evaluate sexual dysfunction in antidepressant drug trials.
abstract: OBJECTIVE
  Sexual dysfunction is an important side effect of serotonergic antidepressants, as it often leads to treatment nonadherence. However, sexual dysfunction is often underestimated in clinical trials submitted in support of drug approval. This is because such assessments are based mainly on unsolicited reporting. As a result, the characterization of sexual adverse events has become an important component of many of the development programs for new antidepressants. The purpose of this article is to discuss US Food and Drug Administration's (FDA's) current thinking on possible approaches to characterizing the effects of drugs on sexual function in depression drug trials.
  
  
  METHODS
  FDA's Division of Psychiatry Products, together with the Division of Biometrics I, in particular the authors of this article.
  
  
  METHODS
  The above-referenced FDA divisions conducted a regulatory science forum on measuring sexual dysfunction in depression trials.
  
  
  METHODS
  Considering the evidence presented and discussed at the forum, we developed our preliminary regulatory views on the scientific issues with regard to study design, study population, use of available scales, testing strategy, and statistical analysis plans.
  
  
  CONCLUSIONS
  Sexual dysfunction associated with antidepressants is an important entity that should be adequately assessed during clinical trials with the use of available instruments and described in product labels. It is important to appreciate the need for a positive control to establish assay sensitivity for any trial evaluating the impact of antidepressant medications on sexual function. Methodological improvement and additional data as well as experience with these approaches will be needed prior to further consideration of a formal regulatory guidance document by the FDA.
authors.affiliation: Division of Psychiatry Products, Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland.
authors.forename: Ni A
authors.initials: NA
authors.lastname: Khin
authors.forename: Phillip D
authors.initials: PD
authors.lastname: Kronstein
authors.forename: Peiling
authors.initials: P
authors.lastname: Yang
authors.forename: Eiji
authors.initials: E
authors.lastname: Ishida
authors.forename: H M James
authors.initials: HM
authors.lastname: Hung
authors.forename: Mitchell V
authors.initials: MV
authors.lastname: Mathis
authors.forename: Ellis F
authors.initials: EF
authors.lastname: Unger
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Temple
mesh_terms: D000928:Antidepressive Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D003865:Major Depressive Disorder / Q000188:drug therapy*; D006801:Humans; D012107:Research Design / Q000592:standards*; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced* / Q000175:diagnosis; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D000928:Antidepressive Agents