Female sexual dysfunction: potential for pharmacotherapy.

The act of sex includes a woman's sexual self and self-image, intimate relationships, family, society and culture. The complexities of her environment, sexual and partner history, past relationships, mental health status, current medical problems and hormonal status all play a role. An interdisciplinary consensus conference panel expanded the former Diagnostic and Statistical Manual of Mental Disorders-IV classifications of female sexual dysfunction to include psychogenic and organic causes of desire, arousal, orgasm and sexual pain disorders that cause personal distress. The US FDA Guidance paper details the recommendations for the clinical development of drugs for the treatment of female sexual dysfunction. In this document, great emphasis is placed on orgasm as a clinical trial endpoint and it would appear that satisfactory sexual intercourse is of secondary importance to the Agency. However, there is no evidence to suggest that the majority of women correlate their sexual enjoyment and satisfaction with numbers of orgasms or even the likelihood of orgasm during a given sexual interaction. Nonetheless, any drug coming through the regulatory agency in the US will need to follow these recommendations. Currently, there are six major pharmaceutical therapeutic paths being pursued for treatment of female sexual disorders and/or postmenopausal symptoms. These include dopaminergic agonists and related substances, melanocortin-stimulating hormones, adrenoceptor antagonists, nitric oxide delivery systems, prostaglandins, and androgens. A number of compounds that target these pathways are undergoing development for female sexual dysfunction. The array of pharmacological agents that are being developed for female sexual dysfunction must prove to be efficacious and have a good safety profile at a time when there are increasing worries that hormonal replacement with estrogen and progestogens are not safe. It is unclear if any of these pharmaceutical pathways will prove to be both safe and effective for the treatment of female sexual disorders; however, studies investigating this area will provide important scientific data for the future.