Management of Female Sexual Dysfunction in Postmenopausal Women by Testosterone Administration: Safety Issues and Controversies

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.