title: Regulatory perspective on clinical trials and end points for female sexual dysfunction, in particular, hypoactive sexual desire disorder: formulating recommendations in an environment of evolving clinical science.
abstract: This article examines the history, current status, and potential future challenges in the development of drugs for female sexual dysfunction (FSD) from the perspective of the United States Food and Drug Administration. In particular, the article focuses on testosterone therapy for hypoactive sexual desire disorder (a component of FSD), and the role of the Division of Reproductive and Urologic Products in facilitating the development of safe and effective therapies for this indication.
authors.affiliation: Division of Reproductive and Urologic Products, Food and Drug Administration, Silver Spring, MD 20993, USA. daniel.shames@fda.hhs.gov
authors.forename: D
authors.initials: D
authors.lastname: Shames
authors.forename: S E
authors.initials: SE
authors.lastname: Monroe
authors.forename: D
authors.initials: D
authors.lastname: Davis
authors.forename: L
authors.initials: L
authors.lastname: Soule
mesh_terms: D002986:Clinical Trials as Topic; D004345:Drug Industry; D005260:Female; D006801:Humans; D007880:Legislation, Drug; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D013739:Testosterone / Q000009:adverse effects / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D013739:Testosterone