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

NCT03028532 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-01-30

No results posted yet for this study

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

Conditions

  • Sports Drug Abuse
  • Abuse of Steroids or Hormones

Interventions

DRUG

Clomid

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

Sponsors & Collaborators

  • Sports Medicine Research and Testing Laboratory

    collaborator INDUSTRY

  • Partnership for Clean Competition

    collaborator OTHER

  • Stuart Willick

    lead OTHER

Principal Investigators

  • Stuart Willick, MD · University of Utah

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2018-01-25
Completion
2018-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028532 on ClinicalTrials.gov