Administration of Clomiphene: Short and Long Term Metabolism in an Anti-Doping Setting

Completed · Phase 1

Conditions studied: Sports Drug Abuse, Abuse of Steroids or Hormones

In brief

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

Key facts

Study ID

NCT03028532

Run by

Stuart Willick

People needed

12

Starts

2017-03-13

Expected to finish

2018-10-15

Last updated by the study team

2020-01-30

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Heidi Jo Hansen — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.