Female sexual dysfunction is a multicausal and multidimensional problem combining biological, psychological and interpersonal determinants. It is age related, progressive and highly prevalent, affecting 20% to 50% of women. Based on epidemiological data from the National Health and Social Life Survey a third of women lack sexual interest and nearly a fourth do not experience orgasm. l Approximately 20% of women report lubrication difficulties and 20% find sex not pleasurable. Female sexual dysfunction has a major impact on quality of life and interpersonal relationships. For many women it has been physically disconcerting, emotionally distressing and socially disruptive.In contrast to the widespread interest in research and treatment of male sexual dysfunction, less attention has been paid to the sexual problems of
In light of various shortcomings of the traditional nosology of women's sexual disorders for both clinical practice and research, an international multi-disciplinary group has reviewed the evidence for traditional assumptions about women's sexual response. It is apparent that fullfilment of sexual desire is an uncommon reason/incentive for sexual activity for many women and, in fact, sexual desire is frequently experienced only after sexual stimuli have elicited subjective sexual arousal. The latter is often poorly correlated with genital vasocongestion. Complaints of lack of subjective arousal despite apparently normal genital vasocongestion are common. Based on the review of existing evidence-based research, many modifications to the definitions of women's sexual dysfunctions are recommended. There is a new definition of sexual interest/desire disorder, sexual arousal disorders are separated into genital and subjective subtypes and the recently recognized condition of persistent sexual arousal is included. The definition of dyspareunia reflects the possibility of the pain precluding intercourse. The anticipation and fear of pain characteristic of vaginismus is noted while the assumed muscular spasm is omitted given the lack of evidence. Finally, a recommendation is made that all diagnoses be accompanied by descriptors relating to associated contextual factors and to the degree of distress.
Introduction Existing definitions of women's sexual disorders are based mainly on genitally focused events in a linear sequence model (desire, arousal and orgasm). Aim To revise definitions based on an alternative model reflecting women's reasons/incentives for sexual activity beyond any initial awareness of sexual desire. Methods An International Definitions Committee of 13 experts from seven countries repeatedly communicated, proposed new definitions and presented at the 2nd International Consultation on Sexual Medicine in Paris July 2003. Main Outcome Measure Expert opinions/recommendations are based on a process that involved review of evidence-based medical literature, extensive internal committee discussion, informal testing and re-testing of drafted definitions in various clinical settings, public presentation and deliberation. Results Women have many reasons/incentives for sexual activity. Desire may be experienced once sexual stimuli have triggered arousal. Arousal and desire co-occur and reinforce each other. Women's subjective arousal may be minimally influenced by genital congestion. An absence of desire any time during the sexual experience designates disorder. Arousal disorder subtypes are proposed that separate an absence of subjective arousal from all types of sexual stimulation, from an absence of subjective arousal when the only stimulus is genital. A new arousal disorder has provisionally been suggested, namely that of persistent genital arousal. Orgasm disorder is limited to absence of orgasm despite high subjective arousal. Dyspareunia includes partial painful vaginal entry attempts as well as pain with intercourse. Variable reflex muscle tightening around the vagina and an absence of abnormal physical findings are noted in the definition of vaginismus. Women's sexuality is highly contextual and descriptors are recommended re past psychosexual development, current context, as well as medical status. Diagnosing sexual disorders need not imply intrinsic dysfunction of the woman's own sex response system. Conclusions The International Definitions Committee has recommended a number of fundamental changes to the existing definitions of women's sexual disorders.
We recommend use of the new female sexual dysfunction diagnostic and classification system based on physiological as well as psychological pathophysiologies, and a personal distress criterion for most diagnostic categories.
Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics. Biomarkers can improve the understanding of diseases as well as therapeutic and off-target effects of drugs. Early implementation of biomarker strategies thus promises to reduce costs and time-to-market as drugs proceed through increasingly costly and complex clinical development programs. The 2003 American Association of Pharmaceutical Sciences/Clinical Ligand Assay Society Biomarkers Workshop (Salt Lake City, UT, USA, October 24-25, 2003) addressed key issues in biomarker research, with an emphasis on the validation and implementation of biochemical biomarker assays, covering from preclinical discovery of efficacy and toxicity biomarkers through clinical and postmarketing implementation. This summary report of the workshop focuses on the major issues discussed during presentations and open forums and noted consensus achieved among the participants on topics from nomenclature to best practices. For example, it was agreed that because reliable and accurate data provide the basis for sound decision making, biomarker assays must be validated in a manner that enables the creation of such data. The nature of biomarker measurements often precludes direct application of regulatory guidelines established for clinical diagnostics or drug bioanalysis, and future guidance on biomarker assay validation should therefore be adaptable enough that validation criteria do not stifle creative biomarker solutions.
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