A data and safety monitoring board (DSMB) halted the treatment portion of a clinical trial of testosterone therapy among older men 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 (100-350 ng/dL) 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. When entering the study, the participants had high levels of obesity, hypertension, diabetes, and high cholesterol and/or triglycerides.
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.
Men in the testosterone group also demonstrated more respiratory and dermatologic problems than did men in the placebo group.
On the positive side, men who received testosterone therapy showed significantly greater improvements in stair climbing while carrying weight and in leg press and chest press strength. Based on the overall findings, the authors concluded that “the small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.”
Basaria S et al. Adverse events associated with testosterone administration. New England Journal of Medicine 2010; 363(2): 109-22