The Moscow study: a randomized, placebo-controlled, double-blind trial of parenteral testosterone undecanoate on the metabolic syndrome components and body composition
Yuliya Tishova1, Svetlana Kalinchenko1, George Mskhalaya1, Farid Saad2,3, Louis J G Gooren4 & Erik J Giltay1
Background: Metabolic syndrome has a high prevalence in male population, leading to the high rate of cardiovascular disease and mortality. Numerous studies show that low androgen levels in men are associated with the metabolic syndrome. This study tested whether normalization of testosterone levels improves metabolic dysregulations and body composition.
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.
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. In the Nebido group, there were significant improvements in weight, body mass index, waist circumference and waist-to-hip ratio (P<0.001). Levels of leptin (P=0.001) and insulin (P=0.04) decreased. There were no changes in glucose and lipids, although there was a statistical trend for a reduction in LDL cholesterol (P=0.07).
Conclusions: Thirty weeks of TU administration strongly improved anthropometric parameters as compared to placebo.