Context: Low testosterone level in men is associated with the metabolic syndrome (MetS) as well as with depressive symptoms, low vitality and sexual dysfunction.
Objective: To assess the effects of testosterone administration on these subjective symptoms, which have not extensively been studied in hypogonadal men with the MetS. Design: randomized, placebo-controlled trial. Setting: academic, ambulatory, referral centre. Patients: 184 men suffering from both the MetS and hypogonadism Intervention: 30 weeks with either parenteral testosterone undecanoate (TU; 1000 mg i.m. testosterone undecanoate; NebidoR) or placebo at baseline, and after 6 and 18 weeks. One hundred and five (92.9%) men receiving TU and 65 (91.5%) receiving placebo completed the 30 week trial.
Main outcome measures: The Beck depression inventory (BDI), Aging Males symptoms (AMS) scale, and international index of erectile function 5-item (IIEF-5) scale at baseline, 18 and 30 weeks were analyzed using multilevel analysis.
Results: The 184 men were aged mean 52.1 years old (S.D. 9.6; range 3569), with a mean body mass index of 35.5 kg/m2 (S.D. 6.7; range 25.154.8), and a mean total testosterone level of 8.0 nmol/l (S.D. 4.0). There were significant improvements in BDI (mean difference versus placebo after 30 weeks: −2.5 points; 95% confidence interval (CI): −0.9; −4.1; P=0.003), AMS (−7.4 points; 95% CI: −4.3; −10.5; P<0.001), and IIEF-5 (+3.1 points; 95% CI: +1.8; +4.4; P<0.001). The effects on the BDI, AMS, and IIEF-5 were strongest in men with baseline total testosterone levels <7.7 mmol/l (i.e. median value).
Conclusions: TU administration may improve depressive symptoms, aging male symptoms and sexual dysfunction in hypogonadal men with the MetS. The beneficial effects of testosterone were most prominent in men with the lowest baseline total testosterone levels.
Prague, Czech Republic
24 - 28 Apr 2010
European Society of Endocrinology