Intrinsa: An Inquiry into Female Sexual Dysfunction and Testosterone

Abstract

In December 2004, the Food & Drug Administration rejected Intrinsa, a testosterone transdermal system for the treatment of hypoactive sexual desire disorder in surgically menopausal women. Intrinsa, as well as the FDA's decision, sparked considerable controversy. Principally, it raised questions about the use of testosterone to treat sexual dysfunction in women. This paper examines the relationship between testosterone and female sexual dysfunction and explores, specifically, whether there is a causal relationship between depressed testosterone levels and sexual problems in women. It discusses normal female sexual response and female sexual dysfunction as well as the association between testosterone and sexual difficulties in normal and surgically menopausal women. Ultimately, this paper concludes that there is little evidence for a causal relationship between low levels of testosterone and sexual dysfunction in normal women, but that depressed testosterone levels may be associated with sexual problems in surgically menopausal women. Though Intrinsa was purportedly created for use in surgically menopausal women, its off-label use by normal women was probable. Facing this widespread use by women unlikely to be helped by testosterone and subject to its unknown adverse side effects, the FDA appropriately requested more safety data before approving Intrinsa.