Planning project for testosterone trials in aging men

描述（由申请人提供）：随着男性年龄的增长，他们的血清睾酮浓度下降，因此到70-80岁时，大约70%的男性的值低于年轻男性。此外，随着年龄的增长，男性还会出现许多其他异常，包括虚弱、脆弱和残疾；性功能障碍;认知障碍;失去活力和幸福感。认为睾丸激素下降可能是导致其他异常的一个原因是，由于已知疾病导致睾丸激素水平低的年轻男性也会出现类似的异常，而这些通常通过替代睾丸激素来纠正。然而，老年男性睾酮替代的结果却不一致。医学研究所睾丸激素和衰老委员会审查了老年男性睾丸激素治疗的数据，并建议在上述四个领域进行一组协调的短期随机、安慰剂对照的睾丸激素疗效试验。

DESCRIPTION (provided by applicant): As men age, their serum testosterone concentrations decrease, so by age 70-80 years, about 70% of men have values subnormal for young men. Also as men age they develop many other abnormalities, including weakness, frailty and disability; sexual dysfunction; impaired cognition; and loss of vitality and sense of wellbeing. One reason for thinking the decrease in testosterone could be a cause of the other abnormalities is that young men who develop a low testosterone due to known disease develop similar abnormalities, and these are usually corrected by replacement of testosterone. Testosterone replacement of elderly men, however, has given inconsistent results. The Testosterone and Aging Committee of the Institute of Medicine reviewed the data on testosterone treatment of elderly men and recommended performing a coordinated set of short-term randomized, placebo-controlled efficacy trials of testosterone in each of the four areas above. The overall goal of this application is to develop, in the course of one year, a protocol for the set of coordinated trials the IOM committee recommended. Toward this goal, we shall pursue these specific aims: 1. Develop a common protocol for all subjects in all trials, including inclusion criteria to ensure that all subjects have a low testosterone and related symptoms; exclusion criteria to protect men at high risk for testosterone-dependent disease; randomized, placebo-controlled design of testosterone treatment; and monitoring for testosterone-dependent diseases. 2. Develop four specific trials in the areas of weakness, frailty and disability; sexual dysfunction; cognitive impairment; and diminished vitality; with entry criteria to include men with abnormalities likely due to low testosterone and exclude men not likely to respond to testosterone. 3. Establish a statistics and data coordinating center to serve the entire set of trials for statistics, project management, core data set, data management plan, data analysis plan, data safety management plan, and development of a clinical research network. 4. Implement aims 1-3 during the planning year by continuing to work within the organizational structure this group of investigators has already established, i.e. working groups overseen by an executive committee, meeting by conference call and in person and keeping strict deadlines.