NCT04207684

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Testosterone injection	250 mg of testosterone cypionate (equivalent to 174,8 mg of testosterone) administered via intramuscular injection in a single dose (2 mL)

Timeline

• Start date: 2020-02-04
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2019-12-23
• Last updated: 2020-07-17

Locations

1 site across 1 country: Spain