NCT04189900

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Triptorelin	Subjects receive a single subcutaneous dose of 0,1 mg of Triptorelin acetate.

Timeline

• Start date: 2019-04-26
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2019-12-06
• Last updated: 2019-12-11

Locations

1 site across 1 country: Spain