Effects of parenteral testosterone undecanoate administration on inflammatory markers: the Moscow study
Svetlana Kalinchenko1, Yuliya Tishova1, George Mskhalaya1, Farid Saad2,3, Louis J G Gooren4 & Erik J Giltay5
Background: Numerous studies (among which, studies of androgen deprivation in men with prostate cancer) show that low androgen levels in men are associated with the metabolic syndrome. Obesity and particularly visceral fat excess is associated with pro-thrombotic and pro-inflammatory states as well. This study tested whether normalization of testosterone levels improves markers of inflammation.
Methods: In a randomized, placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT00696748), 184 men suffering from both the metabolic syndrome and hypogonadism (total testosterone level <12 nmol/l) were included. They were treated for 30 weeks with either parenteral testosterone undecanoate (TU; 1000 mg testosterone undecanoate at baseline, and after 6 and 18 weeks; Nebido) or placebo. 105 (92.9%) men receiving TU and 65 (91.5%) receiving placebo completed the trial. At baseline and after 30 weeks we assessed the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin 1 β (IL-1-β), interleukin-6 (IL-6), IL-10, and tumour necrosis factor-α (TNF-α).
Results: The 184 men were aged between 35 and 70 years old, with a mean age of 51.6 (95% confidence interval (CI): 49.853.4) in the TU group and 52.8 (95% CI: 50.555.0) in the placebo group. The body mass index ranged from 25.1 to 54.8 kg/m2. Inflammation markers IL-1-β (P=0.008), TNF-α (0.03), and CRP (P<0.001) decreased while ESR (P=0.78) and IL-10 (0.15) did not change significantly and a statistical trend was found for IL-6 (P=0.07).
Conclusions: Our findings suggest that 30 weeks of TU administration improves a number of inflammation markers, in hypogonadal men with the metabolic syndrome. These effects might help to reduce the risk of cardiovascular disease.