Testosterone for Old Men

There is a lot that we don’t know about testosterone replacement therapy for older men. We know only a little about its efficacy, and almost nothing about its safety. Not surprisingly then, we don’t know the effective dosage or safe duration of use. And it’s not entirely clear whether it’s FDA-approved. The labeling says testosterone is indicated for replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone, and goes on to specify primary hypogonadism and hypogonadotrophic hypogonadism (primary or acquired). It does not mention the most common condition associated with a deficiency of testosterone.

New testosterone products continue to appear. We reviewed a new testosterone gel (Fortesta) in 2011 and a long-acting depot formulation in March of this year. Two more testosterone gels were approved by the FDA, but have not been marketed yet. The number of these products suggests they are used for something more than the relatively rare disorders listed in their labeling. Concerns about their safety also continue to surface. In our March 3, 2014 issue we reviewed an FDA safety communication about some (unconvincing) reports of increased cardiovascular risk associated with testosterone replacement therapy.

The results of published clinical trials, which usually enrolled fewer patients and went on for a shorter time than we would like, indicate that testosterone treatment can increase bone mineral density, increase muscle mass, and decrease body fat in old men with low testosterone levels. Whether it improves mood, cognition, and sexual function is unclear. But help is on the way. A large (789 men), NIH-sponsored, placebo-controlled trial is in progress. It is designed to test the effect of one year of testosterone replacement therapy on physical function, vitality, cognitive function, sexual function, hemoglobin, coronary artery plaque volume, and bone mineral density in men 65 years and older. This trial is not expected to provide useful information on safety; the authors estimate that they would need to enroll 6000 men and treat them for 6 years to detect a 30% increase in the risk of prostate cancer.

We will have more to say about this study and others on this subject in upcoming issues of The Medical Letter.

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  1. J. Linkewich says:

    Having convinced my internist to initiate a N of 1 trial in this 69 year old with history of diabetes, CAD, no prostate issues, measured low T and etc., and with a chief complaint of disappearing muscles and associated lack of stamina, I can report that efficacy is not a problem. Though I could not measure increased muscle size after 2.5 months of topical therapy, it was palpable as was subjective improvement in strength. Alas, the studies that pointed to adverse cardiovascular outcomes in users prompted my discontinuation. Bottom line for me is that compelling safety data are needed. With acceptable safety data I would restart in a nanosecond and enjoy young-man movement for as long as possible.

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