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

NCT04189900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-12-11

No results posted yet for this study

Summary

Background:

Androgens are used for doping purpose because they can increase muscle mass and strength. These drugs are included in the list of prohibited substances of the World Anti-Doping Agency (WADA). The prohibition of its use has given rise to a great variety of strategies of indirect androgenic doping, whose purpose is to produce a sustained increase in endogenous testosterone.

Triptorelin acetate is a gonadotropin-releasing hormone (GnRH) agonist. Daily subcutaneous administration of triptorelin causes an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), producing a transient increase in testosterone levels. However, prolonged daily administration results in a paradoxical decrease in LH and FSH levels due to desensitization of GnRH receptors, decreasing testosterone production to levels similar to castration.

Thus, the initial flare reaction produced by triptorelin administration could be used by athletes as an indirect androgenic doping method to stimulate the synthesis of endogenous LH and testosterone with the aim of improving physical performance.

Hypothesis:

Subcutaneous administration of triptorelin in healthy subjects allows obtaining positive urine samples that will be used to identify analytical strategies for doping detection. Triptorelin concentrations and its metabolites can be measured in urine.

Objectives:

Primary objective: To measure triptorelin concentrations in urine samples for anti-doping control.

Secondary objectives: To identify triptorelin metabolites in urine. To explore the time window in which the drug or its metabolites can be detected in urine after administration.

Methods:

Phase I, open, non-randomized, uncontrolled clinical trial, with a treatment condition (triptorelin) administered subcutaneously in a single dose to 2 subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Triptorelin

Subjects receive a single subcutaneous dose of 0,1 mg of Triptorelin acetate.

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
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2019-05-15
Completion
2019-05-15

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 NCT04189900 on ClinicalTrials.gov