Planning project for testosterone trials in aging men

随着男性年龄的增长，他们的血清睾丸素浓度会下降，所以到了70-80岁，大约70%的男性 对于年轻人来说，他们的价值观非同寻常。此外，随着男性年龄的增长，他们还会出现许多其他异常，包括 虚弱、虚弱和残疾；性功能障碍；认知受损；失去活力和幸福感-- 是存在的。认为睾丸激素的减少可能是其他异常的一个原因是 由于已知疾病导致睾丸素水平低下的年轻男性也会出现类似的异常， 这些症状通常通过替代睾丸素来纠正。老年男性的睾丸素替代， 然而，给出了不一致的结果。医学研究所的睾酮与衰老委员会 回顾了有关老年男性睾丸激素治疗的数据，并建议进行一组协调的研究 对上述四个领域的睾酮进行短期随机、安慰剂对照疗效试验。 这个应用程序的总体目标是在一年的过程中制定一套 国际移民组织委员会建议的协调试验。为了实现这一目标，我们将实现以下具体目标： 1.为所有试验中的所有受试者制定共同议定书，包括纳入标准，以确保所有受试者 受试者有低睾丸素和相关症状；保护高危男性的排除标准 睾酮依赖型疾病：睾酮治疗的随机、安慰剂对照设计； 监测睾丸激素依赖型疾病。 2.在虚弱、脆弱和残疾领域；性功能障碍；认知领域开展四项具体试验 损伤；和活力减弱；进入标准包括可能由于低血压而出现异常的男性 睾丸激素，并排除对睾丸激素不太可能有反应的男性。 3.建立统计和数据协调中心，为统计、项目全套试验服务 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 发展临床研究网络。 4.在规划年内继续在本组织结构内开展工作，以落实目标1-3 调查组已经成立(由执行委员会监督的工作小组)。 通过电话会议和面对面的方式开会，严格遵守最后期限。

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 well- being. 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 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 statististics, 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, ie working groups overseen by an executive committee, meeting by conference call and in person and keeping strict deadlines.