The Medical Letter on Drugs and Therapeutics
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1490
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Safety of Testosterone Replacement Therapy
Revised 5/2/16: Footnote 7 has been added to Table 1

Three coordinated double-blind, placebo-controlled clinical trials have evaluated the efficacy of one year of testosterone replacement therapy in improving sexual function, physical function, and vitality in a total of 790 men ≥65 years old with moderately low serum testosterone concentrations and symptoms suggesting hypoandrogenism. Sexual function improved modestly, and there appeared to be marginal benefits in some areas of physical function and vitality as well. The trials were not designed to evaluate the safety of testosterone replacement therapy.1

ADVERSE EFFECTS — Testosterone administration has been associated with development of acne, gynecomastia, peripheral edema, and polycythemia. Injections of testosterone undecanoate rarely have caused pulmonary oil microembolism (POME) and anaphylactic reactions. The main concern with testosterone replacement therapy, however, has been ... more      

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