NCT03028532

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stuart Willick · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Sports Drug Abuse
• Abuse of Steroids or Hormones

Interventions

Type	Name	Description
DRUG	Clomid	Participants will self-administer Clomid (50mg oral tablet) once daily for 30 consecutive days

Timeline

• Start date: 2017-03-13
• Primary completion: 2018-01-25
• Completion: 2018-10-15
• First posted: 2017-01-23
• Last updated: 2020-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study