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)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001506189

Acronym

N/A

Enrollment

Registered

2019-10-31

Start date

2019-12-16

Completion date

2020-01-30

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

• 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

Outcome results