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

NCT04042428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-12

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Somatropin injection

Subjects receive a daily subcutaneous dose of 0.2 IU/kg (0.067 mg/kg) of recombinant somatropin (rhGH) during 14 days.

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Ana M Aldea Perona, Dr · IMIM (Hospital del Mar Medical Research Institute)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2020-01-08
Completion
2020-01-08

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042428 on ClinicalTrials.gov