Published online by Cambridge University Press: 17 April 2020
Low testosterone levels in men are associated with the metabolic syndrome (MetS) as well as with depressive symptoms, low vitality and sexual dysfunction.
To assess the effects of testosterone administration on these subjective symptoms, which have not extensively been studied in hypogonadal men with the MetS.
In a randomized, placebo-controlled, double-blind, phase III trial, 184 men suffering from both the MetS and hypogonadism were included. They were treated for 30 weeks with either parenteral testosterone undecanoate (TU; 1000 mg IM testosterone undecanoate, at baseline, and after 6 and 18 weeks; Nebido®) or placebo injections. 105 (92.9%) men receiving TU and 65 (91.5%) receiving placebo completed the 30 week trial. 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 analysed using multilevel analysis.
The mean age was 52.1 years (range: 35-69), with a mean body mass index of 35.5 kg/m2 (SD 6.7), and a mean total testosterone level of 8.0 nmol/L (SD 4.0). There were significant improvements in BDI (mean difference vs. 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 were strongest in men with baseline total testosterone levels < 7.7 mmol/L.
TU administration may improve depressive symptoms, aging male symptoms and sexual dysfunction in hypogonadal men with the MetS.
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