Administration of Clomiphene: Short and Long Term Metabolism in an Anti-Doping Setting
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The window of detection for the clomiphene parent compound and metabolites following a 30-day administration will be identified.
研究概览
简要总结
Clomiphene (Clomid) is a drug FDA approved to treat female infertility, however, it is often used by men in an off-label setting to both treat male infertility and in a multitude of sports disciplines to increase performance.
Study Objectives:
- Determine detection windows for clomiphene and its metabolites in urine following a medium-term administration
- Understand the effect of clomiphene administration on luteinizing hormone (LH), follicle-stimulating hormone (FSH), and serum testosterone (T) concentrations in a longitudinal manner
- Identify changes in current steroidal module of Athlete Biological Passport
详细描述
Clomiphene, pharmaceutically prepared as clomiphene citrate, is a selective estrogen receptor modulator (SERM) with a therapeutic indication to treat female infertility. Though FDA-approved only for use in women, clomiphene is often prescribed off-label to males to treat male infertility and secondary hypogonadism due to its ability to increase serum testosterone levels. Numerous clinical studies have documented both the effectiveness for these indications and safety of clomiphene administration in males. Increasing the concentration of circulating testosterone can have additional effects, including the enhancement of performance in sports. As such, clomiphene is already abused by athletes in several sporting disciplines, including mixed martial arts, cycling, and bodybuilding. Therefore, clomiphene is a prohibited substance under the World Anti-Doping Agency code . Though the parent compound and metabolites of clomiphene are directly detectable in routine anti-doping screening, the urinary detection window and the effect of clomiphene administration on other anti-doping markers are unknown and thus the foci of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Active males who engage in regular exercise between the ages of 18 and 40 on the day of enrollment
- •For this study, regular exercise is defined as: physical activity resulting in an increased heart rate for at least 30 minutes per day, 4-5 days per week.
排除标准
- •Individuals outside of the described age range on the day of enrollment
- •Individuals who are in a Registered Testing Pool for anti-doping purposes, or individuals who for any reason could be subject to doping control testing
- •Individuals who are unwilling or unable to provide blood or urine samples
- •Individuals who do not actively exercise
- •Individuals with any history of cancer, cardiovascular disease, endocrine abnormalities, infertility, hypoandrogenism, renal disease, hepatic disease, neurologic disease, or any psychiatric history
- •Individuals who have previously used anabolic steroids, selective estrogen receptor modulators (SERMs), selective androgen receptor modulators (SARMs), or who are currently using any substances included on the WADA Prohibited List
- •History of venous thromboembolic disease (i.e. deep vein thrombosis or pulmonary embolism)
- •History of untreated cataracts
- •History of intracranial lesions such as pituitary tumors
- •Transaminase elevation greater than 3 times the upper limit of normal (ULN)
- •Moderate or heavy alcohol intake
研究组 & 干预措施
Clomid
All participants will be receiving Clomid and will follow the same study procedures.
干预措施: Clomid (Drug)
结局指标
主要结局
The window of detection for the clomiphene parent compound and metabolites following a 30-day administration will be identified.
时间窗: Day 30 through end of study participation (minimum, Day 72)
◦This will be determined as the amount of time following the final dose (day 30) until clomiphene nor its metabolites are no longer detectable in a urine sample.
次要结局
- Effect of clomiphene administration on serum LH, FSH, and T levels for potential inclusion into a hematological-based longitudinal steroid profile.(Day 30 through end of study participation (minimum, Day 72))
- Effect on current steroidal module of Athlete Biological Passport(Day 30 through end of study participation (minimum, Day 72))
研究者
Stuart Willick
Principal Investigator
University of Utah