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N Engl J Med. 2016 Feb 18;374(7):611-24. doi: 10.1056/NEJMoa1506119.

Effects of Testosterone Treatment in Older Men.

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From 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 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 D



Serum testosterone concentrations decrease as men age, but benefits of raising testosterone levels in older men have not been established.


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.


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.


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; number, NCT00799617.).

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