Generation of Biological Samples Positive to Testosterone for Anti-doping Control

Summary

Background: Testosterone is a steroid widely known to improve physical performance due to its protein-anabolic effect. Like other androgenic anabolic steroids (EAA), testosterone is included on the World Anti-Doping Agency (WADA) list of prohibited substances. EAA are the most detected banned substances in anti-doping controls. Therefore, different analytical strategies are required to improve its detection. Hypothesis: The intramuscular administration of 250 mg of testosterone (cypionate) in healthy subjects allows generating detectable concentrations of the drug in urine. Positive urine samples will enable to identify analytical strategies for doping control. Objectives: Primary objective: To measure the concentrations of testosterone in urine for anti-doping control samples. Secondary objective: To identify metabolites and precursors of testosterone in urine. To assess safety and tolerability of the drug used. Methods: Phase I, open, non-randomized clinical trial, with a treatment condition (testosterone) administered via intramuscular injection to 4 subjects.

Timeline

Start

2020-02-04

Primary completion

2020-02-26

Completion

2020-02-26

Drugs

Indications

No indication recorded.