More Testosterone

As promised in this space 2 years ago, a well-designed, randomized, placebo-controlled clinical trial on the effects of testosterone treatment in older men has been published (NEJM 2016; 374:611) . The Medical Letter will try to keep pace by publishing an article in our next issue (1490; March 14) on the safety of testosterone replacement therapy in older men. But it’s all a little more complicated than that, and not quite as fulfilling as it sounds.

In 2003, the Institute of Medicine began organizing a set of clinical trials that could determine whether testosterone treatment for one year had any positive effects in older men. The panel that undertook this project decided there was no point in pursuing the long-term study that would be required to determine whether testosterone replacement was safe if it proved not to offer any benefits. The Testosterone Trials (PJ Snyder et al. Clin Trials 2014; 11:362) looked for improvements in seven areas, each of which would be tested in a clinical trial: mobility, sexual function, fatigue, cognitive function, hemoglobin concentration, bone density, and coronary artery plaque volume. The New England Journal publication reported the results of the Physical Function (mobility) trial, the Sexual Function trial, and the Vitality (fatigue) trial. Testosterone improved sexual function significantly and had some beneficial effects in the other 2 areas, but not enough to achieve statistical significance in objective measurements.

So where does that leave safety? Well, at least waiting for the results of the other 4 trials. Older men might be willing to put up with a few risks if it would help their cognition, but perhaps not if the only benefit was on sexual function. Or maybe I’ve got that backwards (different strokes…). In any case, no well-designed safety trial is on the horizon, so we thought it might be helpful to say something about what we know and don’t know about the safety of testosterone treatment in older men.

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  1. for the suggestion box: while on the testosterone topic how about discussing alternatives like clomiphene, anastrazole, HCG – efficacy and side effects, at least what is known. thanks.

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