The Saga of Testosterone for Menopausal Women at the Food and Drug Administration (FDA)
James A. Simon, Meredith D. Kapner
Abstract
In the September issue, Davis et al,1 representing a significant number of menopausal and women's sexual health organizations, published the Global Consensus Position Statement on the Use of Testosterone Therapy for Women, which was simultaneously published in Climacteric, The Journal of Clinical Endocrinology and Metabolism, and Maturitas. In that document, the conspicuous absence of Food and Drug Administration (FDA)– and European Medicines Agency–approved testosterone products for women was emphasized in stark contrast to the large number of available approved testosterone products for men. You may be wondering “So, what's up with that?” Ovarian testosterone is a well-known modulator of women's sexual desire and has many clinically significant functions. The androgen receptor is also found throughout the female body, with its stimulation having dynamic and complex effects. Beneficial effects on cardiovascular health, cognition, and bone health, among others, have been reported.2 Although likely not testosterone's primary role in women, it has been most commonly prescribed for treatment of sexual dysfunction and menopausal vasomotor symptoms in combination with estrogens.