Publication: Effects of Testosterone Treatment in Older Men.

Pubmed ID: 26886521

DOI: 10.1056/NEJMoa1506119

Pubmed Central ID: PMC5209754

Journal: The New England journal of medicine

Publication Date: Feb. 18, 2016

Authors: Peter J Snyder¹, Shalender Bhasin, Glenn R Cunningham, Alvin M Matsumoto, Alisa J Stephens-Shields, Jane A Cauley, Thomas M Gill, Elizabeth Barrett-Connor, Ronald S Swerdloff, Christina Wang, Kristine E Ensrud, Cora E Lewis, John T Farrar, David Cella, Raymond C Rosen, Marco Pahor, Jill P Crandall, Mark E Molitch, Denise Cifelli, Darlene Dougar, Laura Fluharty, Susan M Resnick, Thomas W Storer, Stephen Anton, Shehzad Basaria, Susan J Diem, Xiaoling Hou, Emile R Mohler 3rd, J Kellogg Parsons, Nanette K Wenger, Bret Zeldow, J Richard Landis, Susan S Ellenberg, Testosterone Trials Investigators, Peter J Snyder, Elizabeth Barrett-Connor, Shalendar Bhasin, Jane A Cauley, David Cella, Jill P Crandall, Glenn Cunningham, Susan S Ellenberg, Kristine E Ensrud, John T Farrar, Thomas M Gill, Cora E Lewis, Alvin M Matsumoto, Mark E Molitch, Marco Pahor, Susan Resnick, Raymond C Rosen, Ronald S Swerdloff, Susan S Ellenberg, Xiaoling Hou, Alisa Stephens-Shields, J Richard Landis, Bret Zeldow, Liyi Cen, Renee H Moore, Denise Cifelli, Darlene Dougar, Laura Fluharty, Laura Gallagher, Shawn Ballard, Tracy Chai, James Dattilo, Trina Brown, Sandra Smith, Fran Chicchi, Scott E Kasner, Cora E Lewis, Steven R Messe, Emile R Mohler 3rd, Jill P Crandall, Vafa Tabatabaie, Eric Epstein, Uriel Barzel, Gilda Trandafirescu, Glenn R Cunningham, Emilia Cordero, Patti Marino, Shalender Bhasin, Shehzad Basaria, Richard Eder, Erica Appleman, Kathleen Ann Halley, Mark Molitch, Daniel Toft, Amisha Wallia, Diane Larsen, Elaine Massaro, Daphne Adelman, Cora E Lewis, James Shikany, Peter Kolettis, Phillip Johnson, Margaret N Pike, Isabelle J Joffrion, Ronald Swerdloff, Christina Wang, Xiaodan Han, Jamila Ashai, Elizabeth Barrett-Connor, Karen Herbst, Heather Hofflich, J Kellogg Parsons, Noralinda Kamantigue, Mary Lou Carrion-Peterson, Gabriela Reno, Lauren Claravall, Jean Smith, Marco Pahor, Susan Nayfield, Stephen D Anton, Todd Manini, Philip Dahm, Michael Marsiske, Bhanuprasad Sandesara, Melissa Lewis, Mieniecia L Black, Jeffrey Knaggs, William Marena, Jane Ching-ju Lu, Kristine E Ensrud, Susan J Diem, Howard Fink, Christopher Warlick, Sandra Potter, Luanne Welch, Pamela Van Covering, Kristi Lee Jacobson, Lisa Miller, Jane Cauley, Mara J Horwitz, Susan L Greenspan, Thomas M Jaffe, Linda Prebehalla, Janet T Bonk, Jennifer L Rush, Alvin M Matsumoto, Janet Gilchriest, Kathy Winter, Magdalena Wojtowicz, Thomas M Gill, Natalie deRekeneire, Susan Kashaf, Lee Katz, Hamid Mojibian, Joanne McGloin, Karen Wu, Dismayra Martinez, Denise Shepard

Affiliations: Expand

¹
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

MeSH Terms: Prostate-Specific Antigen, Double-Blind Method, Fatigue, Libido, Sexual Behavior, Hormone Replacement Therapy, Walking, Depression, Male, Testosterone, Reference Values, Humans, Aged

Grants: P30-AG013679, R01 AG37679, P30-AG021342, K24-AG021507, DK079626, UL1 TR000142, R01 AG037679, P60 DK079626, P30 DK079626, K07 AG043587, K07AG043587, P30 AG021342, U01 AG030644, K24 AG021507, P30 AG024827, P30 AG028740

Cite As: 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 3rd, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS, Testosterone Trials Investigators. Effects of Testosterone Treatment in Older Men. The New England journal of medicine 2016 Feb 18.

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. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00799617.).