Comparing Direct and Indirect Detection Methods Following Multiple Routes of Testosterone administration-an Anti-doping Perspective
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Detection windows of testosterone administered via injection, oral and skin cream.
研究概览
简要总结
Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues
详细描述
Because human bodies make testosterone naturally, it can be difficult to determine whether the testosterone in your body is natural or if it came from administering testosterone. Currently, testosterone abuse by athletes is detected by anti-doping laboratories in urine samples and use can also be inferred by testing blood samples. As a pharmaceutical preparation, testosterone is available to administer to your body in different ways. However, due to lack of controlled data on the various preparations of testosterone administrations related to the anti-doping field, this study id designed to look at five different testosterone preparations delivered three different ways and how they compare to each other in terms of anti-doping detection and how long they will be in circulation in your body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HEALTHY MALE ADULTS, AGED 18-60 YEARS
排除标准
- •Individuals currently enrolled in a registered testing pool for anti-doping purposes
- •Unwilling to provide urine or blood samples
- •Individuals who are not actively exercising
- •Individuals who show a high risk of heart attack or cardiovascular disease as defined by a physician
- •Individuals that have an elevated baseline hematocrit as determined by the PI
- •Individuals who are diabetic or are currently taking diabetic medications.
- •Individuals that have donated blood (approximately 500 mL) in the past 8 weeks
- •Individuals with severe acne
- •Individuals with a history of cancer, cardiac, renal or hepatic disease
研究组 & 干预措施
Testosterone group two
The participant will receive a single injection of one of three types of testosterone in phase one.
In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.
干预措施: Testosterone injection (Drug)
Testosterone group two
The participant will receive a single injection of one of three types of testosterone in phase one.
In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.
干预措施: Testosterone Oral (Drug)
Testosterone group one
The participant will receive a single injection of one of three types of testosterone in phase one.
In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.
干预措施: Testosterone injection (Drug)
Testosterone group one
The participant will receive a single injection of one of three types of testosterone in phase one.
In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.
干预措施: Testosterone gel (Drug)
结局指标
主要结局
Detection windows of testosterone administered via injection, oral and skin cream.
时间窗: 12 weeks
Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream
Changes in serum concentration of testosterone
时间窗: 12 weeks
Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone
Changes in serum concentration of androstenedione
时间窗: 12 weeks
Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone
Changes in serum concentration of luteinizing hormone
时间窗: 12 weeks
Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone
次要结局
- Direct detection of testosterone esters(12 weeks)