Testerone Trial

睾酮试验

• 批准号: 8147373
• 负责人: PETER J. SNYDER
• 金额: $ 16.58万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-15 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8147373
• 关键词: Activities of Daily Living; Adverse event; Affect; Age; Age-associated memory impairment; Anemia; Area; Biopsy; Bone Density; Cardiovascular Diseases; Clinic; Clinical; Cognition; Controlled Clinical Trials; Data; Decreased Libido; Elderly; Elderly man; Electron Beam; Endocrinology; Fatigue; Fracture; Gait; Gel; Geriatrics; Heart Diseases; Hormonal; Hypogonadism; Impaired cognition; Incidence; Individual; International; Interview; Libido; Measurement; Measures; Memory; Metabolic syndrome; Moods; Osteoporosis; Outcome; Patient Self-Report; Patients; Perception; Personal Satisfaction; Physical Function; Pituitary Diseases; Pituitary Gland; Placebo Control; Placebos; Plant Roots; Production; Prostate; Prostate-Specific Antigen; Prostatic Diseases; Psyche structure; Qualifying; Questionnaires; Randomized; Risk; Rotation; SF-36; Serum; Sex Behavior; Sex Functioning; Short-Term Memory; Site; Speed; Sum; Symptoms; Testicular Diseases; Testing; Testis; Testosterone; Time; Trail Making Test; Vertebral column; Visual; Walking; base; cognitive function; disability; executive function; experience; falls; health related quality of life; impression; improved; indexing; man; men; mental state; muscle form; older men; visual memory

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.

描述（由申请人提供）：随着男性年龄的增长，他们会经历许多情况，如行动障碍、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、摔倒倾向增加和独立性下降。他们还会出现贫血、骨质疏松、代谢综合征和性功能减退。导致这些症状的一个原因是血清睾酮浓度过低。随着男性年龄的增长，他们的血清睾酮水平下降，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睾酮水平低下时，他们也会经历类似的后果，包括肌肉质量和力量下降、性欲下降、认知受损、精力不足，以及贫血、骨质疏松和代谢综合征。当这些人接受睾酮治疗时，所有这些异常都得到了改善。我们提出的概念是，睾丸激素浓度明显低，除了年龄之外没有明显的原因，使男性易患这些老年疾病，而睾丸激素治疗将改善这些疾病。