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降低，因此，到70-80岁时，约70%的男性的值低于年轻男性的正常值。此外，随着年龄的增长，男性会出现许多其他异常情况，包括虚弱、脆弱和残疾;性功能障碍;认知受损;失去活力和幸福感。 认为睾酮减少可能是其他异常的原因之一是，由于已知疾病而导致睾酮水平低的年轻男性也会出现类似的异常，这些异常通常通过睾酮的替代来纠正。然而，老年男性的替代治疗却产生了不一致的结果。医学研究所的睾酮和衰老委员会审查了老年男性睾酮治疗的数据，并建议在上述四个领域中的每一个领域进行一组协调的短期随机，安慰剂对照的睾酮疗效试验。 该申请的总体目标是在一年内为IOM委员会建议的一系列协调试验制定一项方案。为了实现这一目标，我们将努力实现以下具体目标： 1.为所有试验中的所有受试者制定一个共同的方案，包括确保所有受试者都有低睾酮和相关症状的入选标准;保护睾酮依赖性疾病高风险男性的排除标准;睾酮治疗的随机、安慰剂对照设计;以及睾酮依赖性疾病的监测。 2.在虚弱、脆弱和残疾领域开展四项具体试验;性功能障碍;认知障碍;和活力减弱;入选标准包括可能由于低睾酮导致异常的男性，排除不太可能对睾酮有反应的男性。 3.建立统计和数据协调中心，为整套试验提供统计、项目管理、核心数据集、数据管理计划、数据分析计划、数据安全管理计划以及临床研究网络的开发服务。 4.在规划年期间，通过继续在该调查小组已经建立的组织结构内开展工作，即由执行委员会监督的工作组，通过电话会议和亲自开会，并严格遵守最后期限，实现目标1-3。

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.