TESTOSTERONE REPLACEMENT THERAPY — All testosterone replacement products available in the US are FDA-approved for treatment of males with conditions associated with a deficiency or absence of endogenous testosterone. No testosterone products are approved for treatment of low testosterone levels due solely to aging. 

CLINICAL STUDIES — The label changes were based on the results of a double-blind trial (TRAVERSE) and post-marketing ambulatory blood pressure monitoring studies. 

Cardiovascular Outcomes – In the TRAVERSE trial, 5246 hypogonadal men 45-80 years old who had or were at high risk for cardiovascular disease were randomized to receive transdermal testosterone gel (AndroGel 1.62%) or placebo once daily. After a mean follow-up of 33 months, the incidence of a first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death with testosterone was noninferior to that with placebo (7.0% vs 7.3%). The change in mean systolic blood pressure from baseline through 6 months was +0.3 mm Hg with testosterone and -1.5 mm Hg with placebo.2 

Blood Pressure – Based on premarketing studies showing increases in blood pressure with use of oral or subcutaneous testosterone, the FDA required post-marketing studies for all testosterone products. The trials found that testosterone use, regardless of the route of administration, was associated with increases in blood pressure.3-5