Not Yet RecruitingPhase 3Phase 4ACTRN12609000300279

Development of valid immunoassay methods for Luteinising Hormone (LH) in urine.

Detection of exogenous Luteinising Hormone (LH) as a sports doping agent (with and without supression of endogenous LH) in urine of healthy adult male volunteers. An open label, parallel group study.

Sponsor

Sydney South Western Area Health Service (SSWAHS)

Enrollment

4 participants

Start Date

May 4, 2009

Study Type

Interventional

Conditions

Detection of LH in healthy males, as a sports doping agent.

Summary

This study aims to develop effective testing methods for the detection of injected recombinanat luteinising hormone (rLH) excreted in urine. The blood and urine samples taken from male volunteers in this study will be used to develop robust testing for the illicit use of rLH in elite athletes for performance enhancement. Four healthy male adults will be recruited. Two will receive an intramuscular (IM) injection of nanadrolone 200mg, 4 days prior to an intravenous (IV) infusion of 2400iu rLH. Nandrolone is a synthetic androgen which will act to temporarily supress the bodys own LH production. The other two participants will receive an IV infusion of rLH 2400iu ( no nandrolone). Samples of urine will be collected from all participants at 0 to 4 hours, 4 to 8 hours and 8 to 24 hours. Blood samples will be collected at baseline, 1, 2, 3, 4, 6, 8 and 24 hous following rLH infusion.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is developing a reliable urine test to measure luteinising hormone (LH), an important reproductive hormone. It is looking for healthy males aged 18 to 65 who are not taking any testosterone or related supplements. Participation involves providing urine samples for laboratory testing.

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

a) 2 participants will receive 200mg nandrolone decanoate by intramuscular (IM) injection 4 days prior to receiving an intravenous infusion (IV) of 2400iu recombinant luteinising hormone (rLH). b)

a) 2 participants will receive 200mg nandrolone decanoate by intramuscular (IM) injection 4 days prior to receiving an intravenous infusion (IV) of 2400iu recombinant luteinising hormone (rLH). b) 2 particpants will receive in IV infusion of rLH only. All 4 particpants will have blood samples taken prior to commencing the rLH infusion (at 0 minutes) then again at 1,2,3,4,6 and 8 hours. A further blood sample will be taken at 24 hours.

Locations(1)

Australia

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ACTRN12609000300279