Watch the video – Cardiovascular Risks
TRAVERSE (1) is multicentre randomized, double-blind, placebo-controlled, noninferiority trial of testosterone therapy, enrolling 5246 men 45 to 80 years of age who had preexisting or a high risk of cardiovascular disease and who reported symptoms of hypogonadism. The primary cardiovascular safety end point was the first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, assessed in a time-to-event analysis.
For the diagnosis, subjects required two fasting testosterone levels of less than 10.4 nmol/l. Patients were randomly assigned to receive daily transdermal 1.62% testosterone or placebo gel for a mean 27.1 months.
The study was commissioned at the request of the FDA(2) , following the Testosterone in Older Men (TOM) (3 )and Vigen (4) studies , which led to a black box warning on all testosterone products. In contrast the European Medicines Agency (EMA) (5), found no cause for concern.
Recently, seven papers from TRAVERSE have been published addressing cardiovascular safety (1), diabetes (6), prostate (7), anaemia (8), bone (9) depression (10), somatic symptoms and sexual function (1) have been published.
