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

January 29, 2020 updated by: Stuart Willick

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Heidi Jo Hansen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 30 through end of study participation (minimum, Day 72)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 30 through end of study participation (minimum, Day 72)
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.
Day 30 through end of study participation (minimum, Day 72)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stuart Willick

Collaborators

Sports Medicine Research and Testing Laboratory
Partnership for Clean Competition

Investigators

  • Principal Investigator: Stuart Willick, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2017

Primary Completion (Actual)

January 25, 2018

Study Completion (Actual)

October 15, 2018

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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