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Not infrequently, middle-aged and older men with erectile dysfunction (ED) have low testosterone levels. Treatment with a selective phosphodiesterase type 5 inhibitor (such as sildenafil) is considered first-line therapy in such men, but whether testosterone replacement provides additional benefit remains uncertain. In this randomized, double-blind, placebo-controlled trial, 140 participants (age range, 40–70) with ED and low testosterone levels (total testosterone, <330 ng/dL or free testosterone, <50 pg/mL) were treated initially with sildenafil and then were randomized to 14 weeks of daily transdermal testosterone (dose titrated from 5 to 15 g) or placebo.
During a run-in phase in which sildenafil doses were optimized, mean testosterone l…