Introduction. A Food and Drug Administration advisory group has questioned the long-term safety of testosterone administration to postmenopausal women. Although only short-term data exist on safety from the double-blind, placebo-controlled trials, testosterone has been used for more than 50 years. Therefore, some data concerning the long-term safety issues must exist in the literature.
Aim. To review the published data concerning the safety of administration of testosterone to women.
Methods. Review of published articles identified by a search of the Ovid databases and bibliographies from articles identified as dealing with the topics of testosterone or androgen treatment of women.
Results. The major adverse reactions to exogenous androgens are the expected androgenic side effects of hirsutism and acne. High-density lipoprotein levels may be decreased with oral androgens. There are insufficient long-term safety data regarding breast, endometrium, or heart safety to draw strong conclusions, although the data available to date are reassuring.
Conclusions. Testosterone administration to postmenopausal women that result in physiological to slightly supraphysiological serum-free testosterone levels is safe for at least 2 years. Braunstein GD. Management of female sexual dysfunction in postmenopausal women by testosterone administration: Safety issues and controversies. J Sex Med 2007;4:859–866.