Not Yet RecruitingPhase 3Phase 4ACTRN12609000189224

Detection of gonadotropin releasing hormone (GnRH) analogs as doping or masking agents

Detection of gonadotropin releasing hormone (GnRH) analogs as a sports doping agent in healthy male volunteers aged 18 to 50. An open label, randomised, placebo controlled clinical study.


Sponsor

Sydney South Western Area Health Service (SSWAHS)

Enrollment

32 participants

Start Date

Jan 1, 2009

Study Type

Interventional

Conditions

Summary

Sports anti-doping study. The aim of this study is to see what effects on testosterone an injection of a synthetic hormone called GnRH analog has. GnRH analogs are banned in elite sports as they are considered to enhance an athletes performance by increasing the bodies production of testosterone. In this study blood and urine specimens will be collected from healthy male volunteers who have been given several injections a GnRH analog. Some of the volunteers will also be given an injection of testosterone or a drug called nandrolone. These three drugs are all banned in elite athletes, but it is thought that they may be being used in combination illicitly. Some of the volunteers will recieve injections of saline only given as a placebo, this allows us to compare the results with those of the volunteers receiving the drugs. The blood and urine samples taken from the volunteers (before and after the injections) will be analysed to see what effects they have on hormone levels, and will be used to help develop a test to detect the use of GnRH anaolgs by elite athletes.


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study examines how a hormone-related drug (GnRH analog) is processed in the body to help detect its use as a doping agent in sports. It is for healthy males aged 18 to 50 with no recent history of steroid use. Participation involves receiving the study drug and providing urine and blood samples over a period of time.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Particpants will be randomly allocated to one of four treatment groups. Group 1 will receive daily subcutaneous (s/c) injections of saline (placebo) for 4 days. Group 2 will receive daily s/c inject

Particpants will be randomly allocated to one of four treatment groups. Group 1 will receive daily subcutaneous (s/c) injections of saline (placebo) for 4 days. Group 2 will receive daily s/c injections of superactive GnRH analog (Lucrin 1mg) for 4 days. Group 3 will receive daily s/c injections of Lucrin 1mg for 4 days and concurrent administration of 100mg injectable testosterone (T) esters to supress endogenous leutenising hormone (LH) and T production. Group 4 will receive daily s/c injections of Lucrin 1mg for 4 days and concurrent administration of nandrolone decanoate 100mg to supress endogenous LH and T production. Blood and urine samples will be collected from all particpants at intervals from 0 for up to 14 days.


Locations(1)

Australia

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ACTRN12609000189224