The Testosterone Trials (TTrials) were a coordinated set of seven placebo-controlled, double-blind trials in 788 men with a mean age of 72 years to determine the efficacy of increasing the testosterone levels of older men with low testosterone. Testosterone treatment increased the median testosterone level from unequivocally low at baseline to midnormal for young men after 3 months and maintained that level until month 12. In the Sexual Function Trial, testosterone increased sexual activity, sexual desire, and erectile function. In the Physical Function Trial, testosterone did not increase the distance walked in 6 minutes in men whose walk speed was slow; however, in all TTrial participants, testosterone did increase the distance walked. In the Vitality Trial, testosterone did not increase energy but slightly improved mood and depressive symptoms. In the Cognitive Function Trial, testosterone did not improve cognitive function. In the Anemia Trial, testosterone increased hemoglobin in both men who had anemia of a known cause and in men with unexplained anemia. In the Bone Trial, testosterone increased volumetric bone mineral density and the estimated strength of the spine and hip. In the Cardiovascular Trial, testosterone increased the coronary artery noncalcified plaque volume as assessed using computed tomographic angiography. Although testosterone was not associated with more cardiovascular or prostate adverse events than placebo, a trial of a much larger number of men for a much longer period would be necessary to determine whether testosterone increases cardiovascular or prostate risk.
Bibliographical noteFunding Information:
The Testosterone Trials (TTrials) were supported by the National Institute on Aging (NIA), National Institutes of Health (NIH) (grant U01 AG030644), which gave advice about the design and conduct of the trial. The TTrials were also supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurologic Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) provided funding, AndroGel, and placebo gel. S.B. and the Boston Center were supported, in part, by the Boston Claude D. Pepper Older Americans Independence Center (grant 5P30AG031679). A.M.M. was supported by the Department of Veterans Affairs Puget Sound Health Care System. T.M.G. is the recipient of an Academic Leadership Award (grant K07AG043587) from the NIA. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (grant P30AG021342) and Yale Clinical and Translational Science Award (grant UL1TR000142). S.M.R. was supported by the Intramural Research Program, NIA, NIH. C.E.L. was supported by the National Institute for Diabetes, Digestive and Kidney Diseases, NIH (grant DK079626), to the University of Alabama at Birmingham Diabetes Research and Training Center. J.A.C. was supported by the NIA, NIH (grant R01 AG37679)
© 2018 Endocrine Society.