Unmet Medical Needs

6.22.6.1 Precautions of Androgen Therapy in Aging Males

Androgen replacement therapy has been reported to cause water retention, polycythemia, hepatotoxicity, sleep apnea, prostate enlargement, and to reduce HDL cholesterol.3 Hepatic toxicity is associated with derivatives of testosterone rather than pure testosterone. Polycythemia is observed more commonly in males receiving injectable testosterone. Thus, hematocrit should be measured periodically to minimize the risk of polycythemia. HDL cholesterol lowering is more profound with oral methyltestosterone than transdermal or injectable testosterone, but this effect is dose dependent, with higher doses causing more profound lowering of HDL cholesterol. Although testosterone is associated with prostate enlargement and prostate cancer, testosterone replacement therapy is rarely associated with an increase in urinary tract voiding symptoms, leading to cessation of therapy. In addition, prostate cancer surveillance can be done by measurement of PSA during the first 6-month interval after initiating testosterone replacement therapy and at yearly intervals thereafter. There is no compelling evidence to support a causal relationship between prostate cancer induction and testosterone replacement therapy, but further study is needed to exclude such a relationship. Testosterone replacement therapy in hypogonadal males delays time to ischemia, improves mood, and is associated with potentially beneficial reductions of total cholesterol and serum tumor necrosis factor-a (TNF-a).45

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