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J Clin Endocrinol Metab. 2016 Aug;101(8):3096-104. doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29.

Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels.

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Departments of Medicine and Molecular and Cellular Biology (G.R.C.), Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas 77030; Department of Biostatistics and Epidemiology (A.J.S.-S., J.T.F., B.Z., X.H., S.S.E.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104; New England Research Institutes, Inc (R.C.R.), Watertown, Massachusetts 02472; Division of Endocrinology (C.W., R.S.S.), Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90502; Research Program in Men's Health: Aging and Metabolism (S.Bh., S.Ba.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Geriatric Research, Education, and Clinical Center (A.M.M.), Department of Veterans Affairs Puget Sound Health Care System, and Division of Gerontology & Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington 98108-1597; Department of Urology (J.K.P.), Moores Comprehensive Cancer Center, University of California, San Diego, California 92093; Division of Geriatric Medicine (T.M.G.), Yale School of Medicine, New Haven, Connecticut 06510; Division of Endocrinology, Metabolism, and Molecular Medicine (M.E.M.), and Department of Medical Social Sciences (D.C.), Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611; Division of Epidemiology (E.B.-C.), Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, California 92093-0607; Department of Epidemiology (J.A.C.), University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania 15261; Center for Clinical Epidemiology and Biostatistics (D.C., L.G.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104; Divisions of Endocrinology and Geriatrics (



The Testosterone Trials are a coordinated set of seven trials to determine the efficacy of T in symptomatic men ≥65 years old with unequivocally low T levels. Initial results of the Sexual Function Trial showed that T improved sexual activity, sexual desire, and erectile function.


To assess the responsiveness of specific sexual activities to T treatment; to relate hormone changes to changes in sexual function; and to determine predictive baseline characteristics and T threshold for sexual outcomes.


A placebo-controlled trial.


Twelve academic medical centers in the United States.


A total of 470 men ≥65 years of age with low libido, average T <275 ng/dL, and a partner willing to have sexual intercourse at least twice a month.


Men were assigned to take T gel or placebo for 1 year. Sexual function was assessed by three questionnaires every 3 months: the Psychosexual Daily Questionnaire, the Derogatis Interview for Sexual Function, and the International Index of Erectile Function.


Compared with placebo, T administration significantly improved 10 of 12 measures of sexual activity. Incremental increases in total and free T and estradiol levels were associated with improvements in sexual activity and desire, but not erectile function. No threshold T level was observed for any outcome, and none of the 27 baseline characteristics predicted responsiveness to T.


In older men with low libido and low T levels, improvements in sexual desire and activity in response to T treatment were related to the magnitude of increases in T and estradiol levels, but there was no clear evidence of a threshold effect.


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