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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.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000300279
Enrollment
4
Registered
2009-05-19
Start date
2009-05-04
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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) 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.

Sponsors

Sydney South Western Area Health Service (SSWAHS)
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy males aged 18 to 65. Not taking any form of androgens.

Exclusion criteria

History of anabolic steroid use. Poor health.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026