FEMALE SEXUAL DYSFUNCTION DIAGNOSTIC TOOL DEVELOPMENT

DESCRIPTION (provided by applicant): A 1999 National Health and Social Life Survey published in the Journal of the American Medical Association indicated that 43% of American women experience problems with reproductive reactivity in the course of their liv es. Despite the fact that significantly more women than men are afflicted with such disorders, there are comparatively few diagnostic and treatment options for women. A reason for this discrepancy is the difficulty of defining and measuring female disorder s. Similar to erectile dysfunction, these disorders can exist as an isolated physical impairment or as a co-morbidity of diabetes, heart disease, or hypertension. In addition, they can occur as a normal part of menopause and post-partum, or arise as a cons equence of abuse, as a symptom of depression or anxiety, or as a side effect from the various medications treating these conditions. There is an unmet need in research, pharmaceutical trials, and clinical practice for instruments to measure physiological e vents associated with reproductive reactivity. This is a fundamental shortcoming since reproductive reactivity is characterized by a complex interplay of physiological processes. Different disorders can be expressed as anomalies that occur in one physiolog ical indicator but not another, or in several indicators that overlap in time. Current methods remain heavily dependent on patient self-assessment and reporting, and the private nature of these disorders further hinders the collection of reliable and repea table data. The few options for collecting physiological response are (1) of limited functionality, (2) not usable during many types of regular functioning, and (3) must be used in a clinical setting. Because of these limitations, there is a lack of good n ormative data. Corpora Systems aims to develop and test a product that will begin to address these three deficits and become a standard tool for research and pharmaceutical trials, with the potential for use in diagnosis and charting of treatment progress. Clinical trials of the prototype developed in Phase I successfully demonstrated its fundamental efficacy. In Phase II, the instrument will be developed further to prepare for commercial production. Clinical trials will be performed to validate the measure d factors. PUBLIC HEALTH RELEVANCE Approximately 50 million women in America are afflicted with sexual problems at some point in their lives, and these conditions are still poorly understood. The proposed instrument will significantly advance r esearch and potential treatments for Female Sexual Disorders (FSD) by greatly improving measurement of physiological responses associated with sexual function. The instrument will thus have significant impact on the quality of life of millions of women by providing the foundation for improved diagnostic and treatment methods.