Testerone Trial

描述（由申请人提供）：随着男性年龄的增长，他们会经历许多疾病，如行动不便，与年龄相关的记忆障碍和活力低下，导致日常生活活动能力下降，跌倒倾向增加，独立性下降。他们还经历贫血、骨质疏松症和代谢综合征以及性功能下降。可能导致所有这些疾病的一个原因是血清睾酮浓度低。随着男性年龄的增长，他们的血清睾酮水平福尔斯下降，通常与患有垂体和睾丸疾病的年轻男性的水平相当。当年轻男性由于垂体或睾丸疾病而出现低睾酮时，他们会经历类似的后果，包括肌肉质量和力量下降，性欲下降，认知受损和能量低下，以及贫血，骨质疏松症和代谢综合征。当这些人接受睾丸激素治疗时，所有这些异常都会改善。我们提出的概念是，一个明确的低睾酮浓度没有明显的原因以外的年龄倾向于一个男人有这些老年人的条件和睾酮治疗将改善他们。 因此，我们提出了一个密切协调的一组四个，随机，安慰剂对照的临床试验，以测试假设，睾酮治疗一年的男性>65岁谁明确低血清睾酮浓度（<250 ng/dL），以及行动能力障碍、年龄相关记忆障碍、活力低下的症状和客观证据，或性功能减退的患者将显示出比安慰剂治疗更有利的这些参数的变化。我们将在18个研究中心选择1200名男性，随机分配接受睾酮或安慰剂凝胶治疗一年。这四项试验的主要终点将是6分钟步行距离（行动能力障碍）、韦氏记忆量表修订版的段落回忆（年龄相关记忆障碍）、Facit-疲劳量表（活力）和UCLA 7天性功能问卷（性功能）。所有试验的指标将包括患者对变化问题、日常生活活动、福尔斯、PHQ-9和积极和消极影响量表的总体评估，以及对不良事件（包括前列腺疾病）的评估。将通过电子束CT评估男性亚组的心血管疾病;通过定量CT评估脊柱的体积骨密度;以及贫血。 这项研究的潜在意义在于，它最终应该确定睾酮浓度低的老年男性的睾酮治疗是否会改善他们的身体，性和认知功能和活力。这项研究还将提供初步数据，以帮助确定是否有必要对睾酮对临床心脏病，骨折风险和前列腺风险的影响进行长期试验。

DESCRIPTION (provided by applicant): As men age, they experience many conditions, such as mobility disability, age-associated memory impairment, and low vitality, that result in decreased ability to perform activities of daily living, increased propensity to fall, and decreased independence. They also experience anemia, osteoporosis and metabolic syndrome and decreased sexual function. One cause that could contribute to all of these conditions is a low serum testosterone concentration. As men age, their serum testosterone falls, often to levels comparable to those of younger men who have diseases of the pituitary and testes. When young men develop low testosterone due to pituitary or testicular disease, they experience similar consequences, including decreased muscle mass and strength, decreased sexual drive, impaired cognition, and low energy, as well as anemia, osteoporosis and the metabolic syndrome. When these men are treated with testosterone, all of these abnormalities improve. The concept we propose is that an unequivocally low testosterone concentration for no apparent reason other than age predisposes a man to have these geriatric conditions and that testosterone treatment will improve them. We therefore propose a closely coordinated set of four, randomized, placebo-controlled clinical trials to test the hypotheses that testosterone treatment for one year of men >65 years who have unequivocally low serum testosterone concentrations (<250 ng/dL) and both symptoms and objective evidence of mobility disability, age-associated memory impairment, low vitality, or diminished sexual function will show more favorable changes in these parameters than placebo treatment. We shall select 1200 men at 18 sites and randomize them to receive testosterone or placebo gel for one year. Primary end points for these four trials will be six minute walking distance (mobility disability), paragraph recall by the Wechsler Memory Scale Revised (age-associated memory impairment), Facit-fatigue scale (vitality) and UCLA 7-day sexual function questionnaire (sexual function). Measures across all trials will include patient global assessment of change questions, activities of daily living, falls, PHQ-9 and Positive and Negative Affect scales, as well as assessment of adverse events, including prostate diseases. Subsets of men will be assessed for cardiovascular disease by electron beam CT; volumetric bone density of the spine by quantitative CT; and anemia. The potential significance of this study is that it should determine, finally, if testosterone treatment of older men with low testosterone concentrations will improve their physical, sexual and cognitive function and vitality. This study will also provide preliminary data that will help determine if a longer-term trial of the effects of testosterone on clinical heart disease, fracture risk and prostate risk is warranted.