Generation of Biological Samples Positive to Somatropin for Anti-doping Control
Status:
Completed
Trial end date:
2020-01-08
Target enrollment:
Participant gender:
Summary
Background:
Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping
Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990,
as it is known to improve physical performance.
Hypothesis:
The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows
obtaining positive doping samples.
The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum.
Objectives:
Primary objective: To generate enough serum samples positive to recombinant somatropin in
order to be analyzed as control samples by anti-doping laboratories.
Secondary objective: To determine the analytical parameters necessary to detect the
administration of recombinant somatropin in healthy volunteers by direct and/or indirect
methods.
Methods:
Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin
or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study
correspond to basal samples of 2 subjects who do not receive any treatment.