A data and safety monitoring board (DSMB) halted the treatment portion of a clinical trial of testosterone therapy after preliminary data identified adverse cardiovascular effects in the treatment group. The trial was funded by the National Institute on Aging.
The Testosterone in Older Men (TOM) trial randomized 209 men (average age, 74 years) with low testosterone levels and limited mobility to 6 months of therapy with either a testosterone gel or placebo to determine whether the therapy increased strength and the ability to walk and climb stairs (Basaria S et al. N Engl J Med. 2010;363[2]:109-122). The DSMB stopped the treatment phase of the TOM trial on December 31, 2009, after reviewing preliminary data that revealed that 23 of the 106 men who received testosterone experienced cardiovascular events (the risk was constant during the treatment period), including myocardial infarction, heart rhythm disturbances, and elevated blood pressure; only 5 of the 103 men in the placebo group experienced such events.