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

Abstract

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.

Gender differences in the cardiovascular effect of sex hormones

“…142 A meta-analysis of studies conducted in 2,795 women receiving background estrogens, alone or in association with progestins, and androgen supplementation within the physiological range suggested that androgens may be safe and not associated with increased cardio vascular risk, although the overall number of cardiovascular events was low. 2 Indeed, reports suggest that androgen supplementation within the physiological range might improve functional capacity in women with heart failure, 143 which might be related to the effect on muscular strength, as the increase in exercise capacity was not coupled with changes in left ventricular function.…”

Role of Androgens in Sex Differences in Cardiac Damage During Myocardial Infarction

“…Data on the relationship between E2 and CVD risk in men are limited or unreliable despite higher E2 levels measured in men with CAD (18). Few studies have examined endogenous T and CAD in women, with either positive (19) or no (20) correlation between serum levels and CVD reported. In all these studies, steroid levels were measured by immunoassays that provide inaccurate results at low circulating levels (21), which may have contributed to the conflicting findings.…”

Transvaginal dehydroepiandrosterone: an unconventional proposal todeliver a mysterious androgen that has no receptor or target tissue using a strategy with a new name

“…The effects of systemic testosterone on female sexual desire are dramatic and have been documented repeatedly, particularly in the last decade. 6 It is difficult to understand how HPRT from transvaginal DHEA could impact the central nervous system when there is little to no change in circulating sex steroids. 1,3 For two decades, these authors have pursued DHEA and refined the concept of HPRT.…”