DIETARY SUPPLEMENT ANDROSTENEDIONE AND HORMONE LEVELS IN HEALTHY MEN

健康男性膳食补充剂雄烯二酮和激素水平

• 批准号: 6265475
• 负责人: JOEL S FINKELSTEIN
• 金额: $ 0.05万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265475
• 关键词: androgens; androstenedione; dietary supplements; endocrine pharmacology; estrogens; gonadotropins; hormone biosynthesis; human subject; male; nutrition related tag; oral administration; pharmacokinetics

The steroid androstenedione is the direct precursor to testosterone in the synthetic pathway of androgens. Androstenedione is marketed as a "dietary supplement" in oral formulation and sold without prescription. It purported beneficial effects include increasing muscle mass, enhancing athletic performance, and improving sense of well being. The goal of this study is to determine if orally administered androstenedione, when given in standard doses to normal male volunteers for seven days, raises sex steroid levels or suppresses gonadotropins. Normal men ages 20 - 40 will be randomized to receive either 100 mg, 300 mg, or 0 mg (control) of androstenedione for seven days. Detailed pharmokinetic measurements of multiple sex-steroids over 8 hours will be performed on days 1 and 7. On days 2 - 6, baseline and 120 minute samples will be drawn. Gonadtropin levels will be measured daily along with standard chemistries and liver function tests. These measures will allow us to determine if androstenedione is converted to potent androgens or estrogens, suppresses normal feedback of gonadal function or is associated with any short term toxicity.

类固醇雄烯二酮是雄激素合成途径中睾酮的直接前体。 雄烯二酮作为口服制剂的“膳食补充剂”销售，无需处方。 它声称的有益效果包括增加肌肉质量，提高运动成绩，改善幸福感。 这项研究的目的是确定口服雄烯二酮，当给予正常男性志愿者标准剂量7天，提高性类固醇水平或抑制促性腺激素。年龄在20 - 40岁之间的正常男性将随机接受100 mg，300 mg或0 mg（对照）雄烯二酮7天。 将在第1天和第7天进行8小时内多种性类固醇的详细药代动力学测量。 在第2 - 6天，将采集基线和120分钟样本。 将每天沿着测量促性腺激素水平以及标准化学和肝功能检查。 这些措施将使我们能够确定雄烯二酮是否转化为有效的雄激素或雌激素，抑制性腺功能的正常反馈或与任何短期毒性有关。