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They stated that adequately powered RCTs are required to assess the benefits of testosterone in this high-risk population with regard to quality of life, clinical events, and safetyoutcomes. The results were not robust to the inclusion of subclinical and mild TSH-related signs and symptoms, especially cardiovascular and renal health. The study design is based on a randomized control trial conducted between January 2005 and April 2007 in the general population. It compared the safety and clinical outcomes of testosterone injection over 28 weeks in 3,800 testosterone-treated men (aged 40-80 years) and matched men who were taking testosterone for a different purpose. The study enrolled a total of 856 men who received testosterone therapy for more than 2 years. Median age was 44 years. Of the original participants, 918 received testosterone; 945 opted out of treatment before the study began. After the participants enrolled, 611 subjects were randomized to the placebo or testosterone groups, with enrollment randomly separated during the first 3 months (average randomization length was 13.4 months). Baseline characteristics of both groups are reported in Table 1. The primary endpoint of this study was the change from baseline in the clinical laboratory test results of physical and psychological health as measured using the Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton rating scale for depression, and the Medical Outcomes Study Short-Form36 physical examination, administered on an outpatient basis.36 Each participant underwent standardized measures of health at baseline and at the end of treatment. Results: The overall primary end point was a change from baseline in MADRS composite total score, the MADRS composite Hamilton depression score, or the MADRS Hamilton rating scale for depression; however, all of the primary end points were significant at baseline at the lower quartile (P < 0.01) of testosterone concentrations in order to reflect the dose range of 0.025 - 0.05 mmol/L. Of the patients in the placebo group, 4.2% had a significant change (F (1,15) = 1.15, P = 0.06) from baseline in the MADRS composite total score, the MADRS composite Hamilton depression score, or the MADRS Hamilton rating scale for depression; however, this was non-significant at the lower quartile of testosterone in order to reflect the dose range of 0.025 - 0.05 mmol/L. None of the patients in the testosterone group had a significant change, and only 2 patients were considered statistically significant. The secondary endpoint for participants in the placebo group was the change from baseline in physical health for each of the six primary end points (HAM-D, Similar articles: