CompletedPhase 1

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

United States12 participantsStarted 2017-03-13

Plain-language 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

Who can participate

Age range

18 Years – 40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The window of detection for the clomiphene parent compound and metabolites following a 30-day administration will be identified.

Timeframe: Day 30 through end of study participation (minimum, Day 72)

Trial details

NCT IDNCT03028532

SponsorStuart Willick

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-25

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