The sexual effects of testosterone replacement in depressed men: randomized, placebo-controlled clinical trial.

Symptoms of male hypogonadism such as low libido and erectile dysfunction (ED) respond to testosterone (T) replacement. In hypogonadal men with major depressive disorder (MDD), the extent to which T replacement alleviates sexual symptoms of hypogonadism is not known. We conducted 6 week double-blind placebo-controlled clinical trial in men with low and low-normal T levels (i.e., total T <or= 350 ng/dl) and MDD. Men were randomized to receive weekly intramuscular injections of either T enanthate 200 mg or sesame-seed oil (placebo). The primary outcome measure was self-reported sexual functioning. We randomized 30 patients. The mean age was 52(SD +/- 8) years, mean T level 262.5(SD +/- 8) ng/dl, and mean baseline Hamilton Rating Scale for Depression (HAM-D) score 21(SD +/- 8). At baseline, sexual function was low, with the majority reporting having had normal erectile and orgasmic functioning 0-1 time in the preceding month. All patients who received T achieved normalization of their T levels. The HAM-D scores decreased significantly in both T and placebo groups, and there were no significant between-group differences: reduction in mean HAM-D score from baseline to endpoint was 10.1 in patients who received T and 10.5 in those who received placebo. Self-reported sexual functioning improved slightly in both groups; a between-group difference was not detected. Both T replacement and placebo were associated with improvement in sexual function and mood, but differences between T and placebo were not distinguishable.

RCT Entities:   Population Interventions Outcomes