Effects of testosterone treatment in older men

P. J. Snyder, S. Bhasin, G. R. Cunningham, A. M. Matsumoto, A. J. Stephens-Shields, J. A. Cauley, T. M. Gill, E. Barrett-Connor, R. S. Swerdloff, C. Wang, K. E. Ensrud, C. E. Lewis, J. T. Farrar, D. Cella, R. C. Rosen, M. Pahor, Jill P. Crandall, M. E. Molitch, D. Cifelli, D. DougarL. Fluharty, S. M. Resnick, T. W. Storer, S. Anton, S. Basaria, S. J. Diem, X. Hou, E. R. Mohler, J. K. Parsons, N. K. Wenger, B. Zeldow, J. R. Landis, S. S. Ellenberg

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)611-624
Number of pages14
JournalNew England Journal of Medicine
Volume374
Issue number7
DOIs
StatePublished - Feb 18 2016

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Testosterone
Therapeutics
Placebos
Walking
Reference Values
Gels
Serum
Depression
Sexual Behavior
Fatigue
Chronic Disease

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Snyder, P. J., Bhasin, S., Cunningham, G. R., Matsumoto, A. M., Stephens-Shields, A. J., Cauley, J. A., ... Ellenberg, S. S. (2016). Effects of testosterone treatment in older men. New England Journal of Medicine, 374(7), 611-624. https://doi.org/10.1056/NEJMoa1506119

Effects of testosterone treatment in older men. / Snyder, P. J.; Bhasin, S.; Cunningham, G. R.; Matsumoto, A. M.; Stephens-Shields, A. J.; Cauley, J. A.; Gill, T. M.; Barrett-Connor, E.; Swerdloff, R. S.; Wang, C.; Ensrud, K. E.; Lewis, C. E.; Farrar, J. T.; Cella, D.; Rosen, R. C.; Pahor, M.; Crandall, Jill P.; Molitch, M. E.; Cifelli, D.; Dougar, D.; Fluharty, L.; Resnick, S. M.; Storer, T. W.; Anton, S.; Basaria, S.; Diem, S. J.; Hou, X.; Mohler, E. R.; Parsons, J. K.; Wenger, N. K.; Zeldow, B.; Landis, J. R.; Ellenberg, S. S.

In: New England Journal of Medicine, Vol. 374, No. 7, 18.02.2016, p. 611-624.

Research output: Contribution to journalArticle

Snyder, PJ, Bhasin, S, Cunningham, GR, Matsumoto, AM, Stephens-Shields, AJ, Cauley, JA, Gill, TM, Barrett-Connor, E, Swerdloff, RS, Wang, C, Ensrud, KE, Lewis, CE, Farrar, JT, Cella, D, Rosen, RC, Pahor, M, Crandall, JP, Molitch, ME, Cifelli, D, Dougar, D, Fluharty, L, Resnick, SM, Storer, TW, Anton, S, Basaria, S, Diem, SJ, Hou, X, Mohler, ER, Parsons, JK, Wenger, NK, Zeldow, B, Landis, JR & Ellenberg, SS 2016, 'Effects of testosterone treatment in older men', New England Journal of Medicine, vol. 374, no. 7, pp. 611-624. https://doi.org/10.1056/NEJMoa1506119
Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA et al. Effects of testosterone treatment in older men. New England Journal of Medicine. 2016 Feb 18;374(7):611-624. https://doi.org/10.1056/NEJMoa1506119
Snyder, P. J. ; Bhasin, S. ; Cunningham, G. R. ; Matsumoto, A. M. ; Stephens-Shields, A. J. ; Cauley, J. A. ; Gill, T. M. ; Barrett-Connor, E. ; Swerdloff, R. S. ; Wang, C. ; Ensrud, K. E. ; Lewis, C. E. ; Farrar, J. T. ; Cella, D. ; Rosen, R. C. ; Pahor, M. ; Crandall, Jill P. ; Molitch, M. E. ; Cifelli, D. ; Dougar, D. ; Fluharty, L. ; Resnick, S. M. ; Storer, T. W. ; Anton, S. ; Basaria, S. ; Diem, S. J. ; Hou, X. ; Mohler, E. R. ; Parsons, J. K. ; Wenger, N. K. ; Zeldow, B. ; Landis, J. R. ; Ellenberg, S. S. / Effects of testosterone treatment in older men. In: New England Journal of Medicine. 2016 ; Vol. 374, No. 7. pp. 611-624.
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author = "Snyder, {P. J.} and S. Bhasin and Cunningham, {G. R.} and Matsumoto, {A. M.} and Stephens-Shields, {A. J.} and Cauley, {J. A.} and Gill, {T. M.} and E. Barrett-Connor and Swerdloff, {R. S.} and C. Wang and Ensrud, {K. E.} and Lewis, {C. E.} and Farrar, {J. T.} and D. Cella and Rosen, {R. C.} and M. Pahor and Crandall, {Jill P.} and Molitch, {M. E.} and D. Cifelli and D. Dougar and L. Fluharty and Resnick, {S. M.} and Storer, {T. W.} and S. Anton and S. Basaria and Diem, {S. J.} and X. Hou and Mohler, {E. R.} and Parsons, {J. K.} and Wenger, {N. K.} and B. Zeldow and Landis, {J. R.} and Ellenberg, {S. S.}",
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T1 - Effects of testosterone treatment in older men

AU - Snyder, P. J.

AU - Bhasin, S.

AU - Cunningham, G. R.

AU - Matsumoto, A. M.

AU - Stephens-Shields, A. J.

AU - Cauley, J. A.

AU - Gill, T. M.

AU - Barrett-Connor, E.

AU - Swerdloff, R. S.

AU - Wang, C.

AU - Ensrud, K. E.

AU - Lewis, C. E.

AU - Farrar, J. T.

AU - Cella, D.

AU - Rosen, R. C.

AU - Pahor, M.

AU - Crandall, Jill P.

AU - Molitch, M. E.

AU - Cifelli, D.

AU - Dougar, D.

AU - Fluharty, L.

AU - Resnick, S. M.

AU - Storer, T. W.

AU - Anton, S.

AU - Basaria, S.

AU - Diem, S. J.

AU - Hou, X.

AU - Mohler, E. R.

AU - Parsons, J. K.

AU - Wenger, N. K.

AU - Zeldow, B.

AU - Landis, J. R.

AU - Ellenberg, S. S.

PY - 2016/2/18

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N2 - 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.

AB - 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.

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