BACKGROUND Serum testosterone concentrations decrease as men age, but benefits of raising testosterone levels in older men have not been established.
METHODS We assigned 790 men 65 years of age or older with a serum testosterone concentration of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive either testosterone gel or placebo gel for 1 year. Each man participated in one or more of three trials — the Sexual Function Trial, the Physical Function Trial, and the Vitality Trial. The primary outcome of each of the individual trials was also evaluated in all participants.
RESULTS Testosterone treatment increased serum testosterone levels to the mid-normal range for men 19 to 40 years of age. The increase in testosterone levels was associated with significantly increased sexual activity, as assessed by the Psychosexual Daily Questionnaire (P<0.001), as well as significantly increased sexual desire and erectile function. The percentage of men who had an increase of at least 50 m in the 6-minute walking distance did not differ significantly between the two study groups in the Physical Function Trial but did differ significantly when men in all three trials were included (20.5% of men who received testosterone vs. 12.6% of men who received placebo, P=0.003). Testosterone had no significant benefit with respect to vitality, as assessed by the Functional Assessment of Chronic Illness Therapy–Fatigue scale, but men who received testosterone reported slightly better mood and lower severity of depressive symptoms than those who received placebo. The rates of adverse events were similar in the two groups.
CONCLUSIONS In symptomatic men 65 years of age or older, raising testosterone concentrations for 1 year from moderately low to the mid-normal range for men 19 to 40 years of age had a moderate benefit with respect to sexual function and some benefit with respect to mood and depressive symptoms but no benefit with respect to vitality or walking distance. The number of participants was too few to draw conclusions about the risks of testosterone treatment.
(Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00799617.)
N Engl J Med 374;7 nejm.org February 18, 2016. The New England Journal of Medicine Copyright © 2016 Massachusetts Medical Society. All rights reserved.
Authors: Peter J. Snyder, M.D., Shalender Bhasin, M.D., Glenn R. Cunningham, M.D., Alvin M. Matsumoto, M.D., Alisa J. Stephens-Shields, Ph.D., Jane A. Cauley, Dr.P.H., Thomas M. Gill, M.D., Elizabeth Barrett-Connor, M.D., Ronald S. Swerdloff, M.D., Christina Wang, M.D., Kristine E. Ensrud, M.D., M.P.H., Cora E. Lewis, M.D., M.S.P.H., John T. Farrar, M.D., Ph.D., David Cella, Ph.D., Raymond C. Rosen, Ph.D., Marco Pahor, M.D., Jill P. Crandall, M.D., Mark E. Molitch, M.D., Denise Cifelli, M.S., Darlene Dougar, M.P.H., Laura Fluharty, M.P.H., Susan M. Resnick, Ph.D., Thomas W. Storer, Ph.D., Stephen Anton, Ph.D., Shehzad Basaria, M.D., Susan J. Diem, M.D., M.P.H., Xiaoling Hou, M.S., Emile R. Mohler III, M.D., J. Kellogg Parsons, M.D., M.H.S., Nanette K. Wenger, M.D., Bret Zeldow, M.S., J. Richard Landis, Ph.D., and Susan S. Ellenberg, Ph.D., for the Testosterone Trials Investigators
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Authors’ affiliations: the Division of Endocrinology, Diabetes, and Metabolism (P.J.S.), the Department of Biostatistics and Epidemiology (A.J.S.-S., J.T.F., X.H., B.Z., J.R.L., S.S.E.), the Center for Clinical Epidemiology and Biostatistics (D. Cifelli, D.D., L.F.), and the Division of Cardiovascular Disease, Section of Vascular Medicine, Department of Medicine (E.R.M.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Research Program in Men’s Health: Aging and Metabolism, Brigham and Women’s Hospital, Harvard Medical School, Boston (S. Bhasin, T.W.S., S. Basaria), and New England Research Institutes, Watertown (R.C.R.) — both in Massachusetts; the Departments of Medicine and Molecular and Cellular Biology, Division of Diabetes, Endocrinology, and Metabolism, Baylor College of Medicine and Baylor St. Luke’s Medical Center, Houston (G.R.C.); Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs (VA) Puget Sound Health Care System, and the Division of Gerontology and Effects of Testosterone Treatment in Older Men Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine — both in Seattle (A.M.M.); the Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh (J.A.C.); the Division of Geriatric Medicine, Yale School of Medicine, New Haven, CT (T.M.G.); the Department of Internal Medicine and Division of Epidemiology, Department of Family Medicine and Public Health, University of California, San Diego, School of Medicine, La Jolla (E.B.-C.), the Division of Endocrinology, Harbor–UCLA Medical Center (R.S.S., C.W.), and Los Angeles Biomedical Research Institute (R.S.S., C.W.), Torrance, and the Department of Urology, Moores Comprehensive Cancer Center, University of California, San Diego (J.K.P.) — all in California; the Department of Medicine, Division of Epidemiology and Community Health, University of Minnesota (K.E.E., S.J.D.), and Minneapolis VA Health Care System (K.E.E.) — both in Minneapolis; the Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, (C.E.L.); the Department of Medical Social Sciences (D. Cella) and the Division of Endocrinology, Metabolism, and Molecular Medicine (M.E.M.), Feinberg School of Medicine, Northwestern University, Chicago; the Department of Aging and Geriatric Research, University of Florida, Gainesville (M.P., S.A.); the Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, NY (J.P.C.); the Laboratory of Behavioral Neuroscience, National Institute on Aging, National Institutes of Health, Baltimore (S.M.R.); and the Division of Cardiology, Emory University School of Medicine, Atlanta (N.K.W.).