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In 2015, the U.S. FDA called on manufacturers of testosterone products to conduct additional studies on cardiovascular (CV) safety, because previous research on this matter was inconclusive. Now, results of an industry-funded, randomized trial that involved 5200 men (age range, 45–80; mean age, 63) have been published. Enrollment criteria included known CV disease or multiple CV risk factors, two fasting serum testosterone levels between 100 and 300 ng/dL, and “symptoms of hypogonadism” (defined by the authors as including decreased libido, erectile dysfunction, fatigue, and low mood). Participants received transdermal 1.62% testosterone gel or placebo; testosterone doses were adjusted to a target testosterone level of 350 to 750 ng/dL.
Mean…