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

• Status: Completed
• Trial end date: 2018-10-15
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stuart Willick
• Collaborators: Partnership for Clean Competition; Sports Medicine Research and Testing Laboratory
• Treatments: Clomiphene; Enclomiphene; Zuclomiphene

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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