Cunningham Glenn R, Stephens-Shields Alisa J, Rosen Raymond C, Wang Christina, Bhasin Shalender, Matsumoto Alvin M, Parsons J Kellogg, Gill Thomas M, Molitch Mark E, Farrar John T, Cella David, Barrett-Connor Elizabeth, Cauley Jane A, Cifelli Denise, Crandall Jill P, Ensrud Kristine E, Gallagher Laura, Zeldow Bret, Lewis Cora E, Pahor Marco, Swerdloff Ronald S, Hou Xiaoling, Anton Stephen, Basaria Shehzad, Diem Susan J, Tabatabaie Vafa, Ellenberg Susan S, Snyder Peter J
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 (
J Clin Endocrinol Metab. 2016 Aug;101(8):3096-104. doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29.
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.
睾酮试验是一组七项协调进行的试验，旨在确定睾酮对65岁及以上有明显低睾酮水平的有症状男性的疗效。性功能试验的初步结果表明，睾酮改善了性活动、性欲和勃起功能。
评估特定性活动对睾酮治疗的反应性；将激素变化与性功能变化相关联；确定性结果的预测性基线特征和睾酮阈值。
一项安慰剂对照试验。
美国的12个学术医疗中心。
共有470名65岁及以上性欲低下、平均睾酮水平<275 ng/dL且伴侣愿意每月至少进行两次性交的男性。
男性被分配服用睾酮凝胶或安慰剂1年。每3个月通过三份问卷评估性功能：性心理日常问卷、性功能德罗加蒂斯访谈和国际勃起功能指数。
与安慰剂相比，服用睾酮显著改善了12项性活动指标中的10项。总睾酮、游离睾酮和雌二醇水平的逐步升高与性活动和性欲的改善相关，但与勃起功能无关。未观察到任何结果的睾酮阈值水平，27项基线特征中没有一项能预测对睾酮的反应性。
在性欲低下和睾酮水平低的老年男性中，睾酮治疗后性欲和性活动的改善与睾酮和雌二醇水平升高的幅度有关，但没有明确的阈值效应证据。
