Objective Men with the metabolic syndrome (MetS) have low plasma testosterone (T) levels. The aim of this study was to establish whether the normalization of plasma T improves the features of the... Show moreObjective Men with the metabolic syndrome (MetS) have low plasma testosterone (T) levels. The aim of this study was to establish whether the normalization of plasma T improves the features of the MetS. Design A randomized, placebo-controlled, double-blinded, phase III trial of 184 men suffering from both the MetS and hypogonadism. Patients One hundred and eighty-four men, aged 35-70, with the MetS and hypogonadism (baseline total T level <12.0 nm or calculated free T level <225 pm.), recruited in the outpatient andrology and urology clinic, Research Center for Endocrinology in Moscow, Russia. Intervention Treatment for 30 weeks with either parenteral T undecanoate (n = 113; TU; 1000 mg IM) or placebo (n = 71), administered 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 trial. Measurements Body weight, body mass index (BMI), waist circumference (WC), hip circumference, waist-to-hip ratio, insulin, leptin, glucose, cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, C-reactive protein (CRP), interleukin-1-beta (IL-1 beta), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumour necrosis factor-alpha (TNF-alpha). Results There were significant decreases in weight, BMI and WC in the TU vs placebo group. Levels of leptin and insulin also decreased, but there were no changes in serum glucose or lipid profile. Of the inflammatory markers, IL-1 beta, TNF-alpha and CRP decreased, while IL-6 and IL-10 did not change significantly. Conclusions Thirty weeks of T administration normalizing plasma T in hypogonadal men with the MetS improved some components of the MetS and a number of inflammatory markers. Show less
Introduction. Low testosterone levels in men are associated with the metabolic syndrome (MetS) as well as with depressive symptoms, low vitality, and sexual dysfunction. Aim. To assess the effects... Show moreIntroduction. Low testosterone levels in men are associated with the metabolic syndrome (MetS) as well as with depressive symptoms, low vitality, and sexual dysfunction. Aim. To assess the effects of testosterone administration on these subjective symptoms, which have not extensively been studied in hypogonadal men with the MetS. Main Outcome Measures. The Beck Depression Inventory (BDI-IA), 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. Methods. In a randomized, placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT00696748), 184 men suffering from both the MetS and hypogonadism were included. They were treated for 30 weeks with either parenteral testosterone undecanoate (TU; 1,000 mg IM TU, at baseline, and after 6 and 18 weeks; Nebido (R)) or placebo injections, 105 (92.9%) men receiving TU and 65 (91.5%) receiving placebo completed the 30-week trial. Results. The 184 men were aged mean 52.1 years old (standard deviation [SD] 9.6; range 35-69), with a mean body mass index of 35.5 kg/m2 (SD 6.7; range 25.1-54.8), and a mean total testosterone level of 8.0 nmol/L (SD 4.0). There were significant improvements in BDI-IA (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 on the BDI-IA, 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 evident in men with the lowest baseline total testosterone levels. Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJG, Saad F, and Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med 2010;7:2572-2582. Show less
