Intra-Subject Hormone Variation

产品说明：（由申请人提供）缺乏可靠的数据来估计受试者体内雄性激素随时间的变化（短期和长期），这是男性生殖内分泌学领域的一个明显缺陷。来自我们的马萨诸塞州男性衰老研究（MMAS）的数据表明，随着时间的推移，性腺功能减退症可能不是一种稳定的综合征。此外，受试者内变异性的数据对于设计任何科学可信的男性雄激素替代试验至关重要。这些数据在患者护理水平上也很重要-特别是用于诊断目的的单一清晨血清样本的充分性。 本研究有三个主要目的：（1）获得成年男性激素水平短期（每日）和长期（6个月）受试者内变化的可靠估计。虽然主要关注的是睾丸激素（总雄激素、游离雄激素、生物利用度和游离雄激素指数），其他主要激素（DHT、SHBG、LH、催乳素、DHEA、DHEAS、皮质醇、雄烯二酮、雄甾烷葡糖苷酸（3-α-二醇G）和雌酮）被包括在内，因为对它们的作用的兴趣迅速增长，并且因为在一项研究中收集这些数据也具有成本效益;（2）确定受试者内激素水平的变化是否随年龄而变化（一些研究集中在相对年轻的男性）;（3）检查任何季节性变化的幅度（这可能影响临床试验结果的临床解释和功效计算）。同样重要的是，估计检测变异和生物学变异对总受试者内变异的相对贡献。 这项拟议的研究建立在近20年的MMAS工作基础上，结果将在几个层面产生影响-男性内分泌变化的流行病学，临床试验设计和雄激素缺乏症个体患者的临床管理。

DESCRIPTION: (provided by applicant) The dearth of reliable data to permit estimation of intra-subject variability in male hormones over time (both short and longer-term) is a glaring deficiency in the field of male reproductive endocrinology. Data from our Massachusetts Male Aging Study (MMAS) suggests that hypogonadism may not be a stable syndrome over time. Moreover, data on intra-subject variability is essential to the design of any scientifically credible trial of androgen replacement in men. These data are also important at the level of patient care- especially the adequacy of a single early morning serum sample for diagnostic purposes. This study has three primary aims: (1) To obtain reliable estimates of short term (day-to-day) and longer-term (six months) intra-subject variation in hormone levels in adult men. While the main focus is on testosterone (total, free, bioavailable and the free androgen index), other major hormones (DHT, SHBG, LH, prolactin, DHEA, DHEAS, cortisol, androstenedione, androstanediol glucoronide (3-alpha-diol G) and estrone) are included because of rapidly growing interest in their actions, and because it's cost-efficient also to gather these data in a single study; (2) To determine if the intra-subject variation in hormone levels changes with age (a few studies have focused on relatively young men); (3)To examine the magnitude of any seasonal variability (this could affect clinical interpretation of results and power calculations in clinical trials). It is also important to estimate the relative contribution of assay variation and biological variation to total intra-subject variation. The proposed research builds on nearly 20 years of work on the MMAS and results will have an impact at several levels- the epidemiology of male endocrine change, clinical trials design and the clinical management of individual patients with androgen deficiency.