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

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ClinicalTrials.gov Identifier: NCT03028532
Recruitment Status : Unknown
Verified October 2017 by Stuart Willick, University of Utah.
Recruitment status was:  Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Sports Medicine Research and Testing Laboratory
Partnership for Clean Competition
Information provided by (Responsible Party):
Stuart Willick, University of Utah

Brief 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

Condition or disease Intervention/treatment Phase
Sports Drug Abuse Abuse of Steroids or Hormones Drug: Clomid Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Administration of Clomiphene: Short and Long Term Metabolism in an Anti-Doping Setting
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clomid
All participants will be receiving Clomid and will follow the same study procedures.
Drug: Clomid
Participants will self-administer Clomid (50mg oral tablet) once daily for 30 consecutive days
Other Names:
  • Clomiphene
  • Clomifene




Primary Outcome Measures :
  1. The window of detection for the clomiphene parent compound and metabolites following a 30-day administration will be identified. [ Time Frame: Day 30 through end of study participation (minimum, Day 72) ]
    ◦This will be determined as the amount of time following the final dose (day 30) until clomiphene nor its metabolites are no longer detectable in a urine sample.


Secondary Outcome Measures :
  1. Effect of clomiphene administration on serum LH, FSH, and T levels for potential inclusion into a hematological-based longitudinal steroid profile. [ Time Frame: Day 30 through end of study participation (minimum, Day 72) ]
    A baseline for LH, FSH, and T will be established using the average of serum concentrations calculated from the pre-administration samples from each subject.The change in serum concentrations following administration will be compared against the baseline values.

  2. Effect on current steroidal module of Athlete Biological Passport [ Time Frame: Day 30 through end of study participation (minimum, Day 72) ]
    ◦The steroidal module of the Athlete Biological Passport, a statistical model used to identify doping, will be used for data analysis in this study.As stated in the ABP Operating Guidelines, the steroidal compounds described above are considered for the ABP steroidal module in addition to the following ratios: T/E, A/T, A/Etio, 5aAdiol/5βAdiol, and 5aAdiol/E. Changes in the urinary steroid concentrations and these ratios will be assessed over the course of the study.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028532


Locations
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United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Stuart Willick
Sports Medicine Research and Testing Laboratory
Partnership for Clean Competition
Investigators
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Principal Investigator: Stuart Willick, MD University of Utah

Additional Information:
Publications:

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Responsible Party: Stuart Willick, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03028532     History of Changes
Other Study ID Numbers: 97194
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stuart Willick, University of Utah:
Healthy Volunteers
Sports Medicine
Anti-doping
Athletes
Men's Health
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators