TerminatedPhase 4ACTRN12619001506189

Detection of Testosterone Microdosing in Healthy Men

Detection of Testosterone Microdosing in Healthy Men with an emphasis on profiling effect of the WADA’s Athletes Biological Passport (ABP)


Sponsor

Sydney local Health District

Enrollment

6 participants

Start Date

Dec 16, 2019

Study Type

Interventional

Conditions

Summary

This study aims to determine the effectiveness (sensitivity and specificity) of individual serum and urine steroid, hematological and peptide hormone profiles within the Athletes Biological Passport to detect testosterone micro-dosing in men, and determine the applicability of venous and capillary blood analysis as complimentary testing procedures to those stated for the Athletes Biological Passport. Furthermore, the data for individuals would be collated and evaluated to include legal planning and expert opinion as to how a case against a potentially doping athlete could be undertaken and what data would be required. This information would enable WADA laboratories to identify future testing requirements of samples to ensure all applicable data is available for the Athletes Biological Passport.


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria2

  • Healthy men aged over 18 years of age
  • Provide written, informed consent and willing to comply with all study requirements

Exclusion Criteria8

  • Contraindications to testosterone administration (prostate or breast cancer, untreated sleep apnea or polycythemia)
  • Allergy to peanuts
  • Bleeding disorder or taking anti-coagulant drugs
  • Major, serious or chronic medical disorders including chronic viral infections (HIV, hepatitis) requiring regular prescribed medication;
  • Regular use of medications that interferes with metabolism of testosterone
  • History of androgen or other drug abuse within last year
  • Major psychiatric disease or psychological condition that limits understanding and compliance with study requirements in the opinion of the investigator
  • Men in competitive sporting teams subject to WADA or other occupational drug testing that would disclose testosterone administration

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Interventions

Weekly intramuscular injection of 50mg (0.2ml) for three weeks of mixed testosterone esters -testosterone propionate 30mg, testosterone phenylpropionate 60mg, testosterone isocaproate 60mg, testostero

Weekly intramuscular injection of 50mg (0.2ml) for three weeks of mixed testosterone esters -testosterone propionate 30mg, testosterone phenylpropionate 60mg, testosterone isocaproate 60mg, testosterone decanoate 100mg. Injections are given by trained registered nurses in a hospital setting.


Locations(1)

Concord Repatriation Hospital - Concord

NSW, Australia

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ACTRN12619001506189