Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in levels of serum total testosterone concentration
研究概览
简要总结
In this case-controlled, observational study, 24 subjects will participate in a 12-hour blood collection with a single blood draw at +24 hours. 12 men will have low testosterone levels (hypogonadism) and 12 men will have normal testosterone levels. Blood samples will be drawn every 2 hours and later analyzed for total testosterone and calculated free testosterone. The primary objective of this study is to assess the degree of diurnal variation in men with testosterone deficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men with testosterone deficiency:
- •Ability to read, write, and understand English
- •Male sex at birth
- •Age greater than or equal to 18
- •Age less than 46
- •Diagnosed with testosterone deficiency prior to visit 1
- •Screening testosterone concentration of less than 350 ng/dL
- •Willing and able to comply with the study protocol
- •Willing to provide informed consent for this study
- •No previous exposure to exogenous T unless off therapy for at least 4 weeks
- •Men without testosterone deficiency:
- •Ability to read, write, and understand English
- •Male sex at birth
- •Age greater than or equal to 18
- •Age less than 46
- •Never diagnosed with testosterone deficiency
- •Screening testosterone concentration of greater than 350 ng/dL
- •Willing and able to comply with the study protocol
- •Willing to provide informed consent for this study
- •No previous exposure to exogenous T
排除标准
- •Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 4 weeks
- •Serious psychiatric disease or uncontrolled medical illness, as suspected from the history or clinical examination
- •Used any sex hormones or steroidal anabolic drug supplements within 28 days before screening testosterone collection
- •Incapable of giving informed consent or complying with the protocol
结局指标
主要结局
Change in levels of serum total testosterone concentration
时间窗: 24 hours
Blood samples analyzed by Beckman assays and equipment
Change in levels of serum calculated free testosterone concentration
时间窗: 24 hours
Blood samples analyzed by Beckman assays and equipment
次要结局
- Change in levels of estradiol(24 hours)
- Change in levels of serum LH(24 hours)
- Change in levels of serum FSH(24 hours)
- Change in levels of serum SHBG(24 hours)
- Change in levels of whole blood hematocrit(24 hours)
研究者
Dr. Abraham Morgentaler
Director
Men's Health Boston