Current perspectives on the clinical assessment and diagnosis of female sexual dysfunction and clinical studies of potential therapies: a statement of concern.

INTRODUCTION The assessment and diagnosis of female sexual dysfunction (FSD) are in a state of transition because of evolving concepts of female sexuality and suggested changes to the FSD diagnostic framework. AIM To review the problems with current FSD diagnosis. METHODS Multidisciplinary experts from five countries were assembled to convene a "Postmenopausal FSD Roundtable on specific topics related to FSD." MAIN OUTCOME MEASURE Expert opinion was based on a review of evidence-based medical literature, presentation, and internal discussion. RESULTS Current FSD diagnosis is challenging because of poorly defined distinctions between normal and abnormal, a limited ability to integrate subjective and objective findings and an inability to incorporate contextual factors that play a significant role in sexual behavior. The availability of self-administered questionnaires (SAQs) that assess various domains of female sexual function, as well as those developed specifically for postmenopausal women, suggests that a more structured approach to assessment and diagnosis may be possible. Several SAQs reflecting proposed changes to the FSD diagnostic framework by the American Foundation for Urologic Disease (AFUD), including the Sexual Function Questionnaire (SFQ) and the Female Sexual Distress Scale (FSDS), have been introduced and recently incorporated into a Structured Diagnostic Method (SDM). Recent regulatory decisions and events affecting the development of FSD interventions have highlighted the lack of consensus with regard to clinically meaningful FSD outcomes, as well as shortcomings in a U.S. Food and Drug Administration draft document that provides the primary guidance for conducting FSD clinical studies in the United States. CONCLUSIONS Given the high cost and inherent risk of clinical studies, continued development efforts toward FSD therapies are unlikely to proceed in the absence of significant changes in regulatory guidance that reflect the current understanding of FSD and incorporate validated assessment tools.