Purpose Testosterone (T) therapy in older men with low serum T levels increases lean body mass (LBM) and decreases fat mass (FM). These changes might improve physical performance and strength; however, it has not been established whether T therapy improves functional outcome in older men. Moreover, concerns exist about the impact of T therapy on the prostate in older men. The administration of finasteride, which blocks the conversion of T to the more potent androgen, dihydrotestosterone (DHT), attenuates the impact of T replacement on prostate size and PSA. We hypothesized that T replacement in older hypogonadal men would improve physical performance and that the addition of finasteride to T would not impact these T-induced improvements.
Methods and Results Seventy men with low serum T (≤350ng/dl), age 65 and older, were randomly assigned to receive one of three regimens for 36 months: T enanthate 200 mg intramuscularly every two weeks with placebo pills daily (T-only), T enanthate 200 mg every two weeks with 5 mg finasteride daily (T+F), or placebo injections and pills (placebo). We obtained serial measurements of timed physical performance, grip strength, lower extremity strength, body composition (by DEXA), fasting cholesterol profiles and hormones. After 36 months, T therapy significantly improved performance in a timed functional test when compared to baseline and placebo (4.3±1.6% [mean± SEM, T-only] and 3.8±1.0% [T+F] vs. -5.6±1.9% for placebo, [P≤0.002 for both T and T+F versus placebo; and increased handgrip strength compared to baseline and placebo [P≤0.05]. T therapy increased LBM, and decreased FM, total cholesterol, low-density lipoprotein (LDL-C), and leptin, without affecting high-density lipoprotein (HDL), adiponectin or fasting insulin levels.
Summary T therapy in older men with low serum T improves physical performance, strength, LBM, FM, and serum cholesterol over 36 months both when administered alone or when combined with finasteride.
Conclusion These data suggest that T therapy may improve functional outcome in older men with low serum T and that DHT is likely not essential for these beneficial effects of T.
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