A randomized, double-blind, placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up

Introduction: The clinical significance of low to low-normal testosterone (T) levels in men remains debated. Aim: To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL). Methods: Randomized, double-blind, placebo-controlled study. Men, aged 50-80 years, with serum total T < 15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males' Symptoms (AMS) total score > 36, received 6 months treatment with transdermal 1% T gel (5-7.5 mg/day; n = 183) or placebo gel (n = 179), followed by 12 months open-label with T in all. Results: After 6 months, LBM increased in T-treated patients by 1.28 +/- 0.15 kg (mean +/- SE) and FM decreased by 1.16 +/- 0.16 kg, with minor changes with placebo (LBM +0.02 +/- 0.10 kg and FM -0.14 +/- 0.12 kg; all p < 0.001, T group vs. placebo). Changes were largely similar across subgroups of age, baseline total testosterone, and baseline BMI. Total HRQoL improved compared with placebo (p < 0.05, T group vs. placebo). Conclusions: Six months 1% T gel improved body composition and HRQoL in symptomatic men with low to low-normal T, with further improvements over the following 12 months.