The Moscow Study: a randomized, placebo-controlled, double-blind trial of parenteral testosterone undecanoate on the prostate status and blood count
George Mskhalaya1, Svetlana Kalinchenko1, Yuliya Tishova1, Farid Saad2,3, Louis J G Gooren4 & Erik J Giltay5
Background: For many years testosterone therapy in men was considered to be a risk factor for increasing the PSA level and prostate volume as well as blood count parameters. Objective was to investigate the influence of testosterone therapy on prostate and blood count in men with metabolic syndrome and hypogonadism.
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. PSA total, red blood cells, hemoglobin and hematocrit were measured, and prostate ultrasound was done before and after 30 weeks of treatment.
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, levels of hemoglobin rose significantly as did the red blood cell counts and the hematocrit, but values did not exceed the upper limit of the reference range. In both the placebo group and the testosterone treatment group values of PSA did not rise significantly. Prostate volume did not increase over the treatment period. Levels of PSA and prostate volume were not significantly different after 30 weeks in the men with testosterone treatment compared to the placebo group.
Conclusion: Testosterone treatment in men didnt lead to any change in prostate safety parameters. Blood count monitoring should be performed in men receiving testosterone treatment dose adjustment may be required.