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
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.
- 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|
|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|
All participants will be receiving Clomid and will follow the same study procedures.
Participants will self-administer Clomid (50mg oral tablet) once daily for 30 consecutive days
- 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.
- 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.
- 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.
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
|United States, Utah|
|University of Utah Orthopaedic Center|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Stuart Willick, MD||University of Utah|