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

Stuart Willick

Status and phase

Completed

Phase 1

Conditions

Sports Drug Abuse

Abuse of Steroids or Hormones

Treatments

Drug: Clomid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03028532

97194

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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