Testosterone therapy in women with androgen deficiency: Its time has come.

The concept that women may have a testosterone deficiency is controversial, as is the possibility of testosterone replacement therapy for women. It has been stated that androgen deficiency is a new concept; however, women have been treated off-label for more than 50 years. A number of objections to such therapy in women have been reviewed and discussed, including the lack of a normal age-related concentration range for androgens, the lack of randomized, placebo-controlled clinical trials, and the possibility of chronic adverse effects, particularly the risk of cardiovascular disease and breast cancer. However, recent data have adequately addressed these concerns. Moreover, the 4-year safety data that are available for women is more than that available for testosterone replacement in men. Although more precise diagnostic techniques to measure total testosterone and free testosterone in women would be welcome, it is believed that physicians are able to identify women at risk of testosterone deficiency and safely replace these hormones in carefully selected patients.