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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of valid immunoassay methods for Luteinising Hormone (LH) in urine.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Detection of LH in healthy males, as a sports doping agent. 4624 0
Condition category
Condition code
Metabolic and Endocrine 4924 4924 0 0
Normal metabolism and endocrine development and function

Study type
Description of intervention(s) / exposure
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.
Intervention code [1] 4383 0
Treatment: Drugs
Comparator / control treatment
The group receiving nandrolone will be compared with the non nandrolone group. The baseline samples of each particpant will be compared with subsequent samples provided.
Control group

Primary outcome [1] 5771 0
A demonstrated rise in urinary rLH (detected by immunoassay), samples of which will be used to develop valid immunoassay measurements for use in sports anti-doping testing.
Timepoint [1] 5771 0
All urine passed between 0 and 4 hours, 4 and 8 hours and 8 to 24 hours will be collected as 3 seperate collections.
Secondary outcome [1] 241731 0
Serum samples for LH and testosterone levels.
Timepoint [1] 241731 0
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. All samples will be stored for later analysis.

Key inclusion criteria
Healthy males aged 18 to 65.
Not taking any form of androgens.
Minimum age
18 Years
Maximum age
65 Years
Can healthy volunteers participate?
Key exclusion criteria
History of anabolic steroid use.
Poor health.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3 / Phase 4
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4805 0
Government body
Name [1] 4805 0
World Anti-Doping Agency (WADA)
Address [1] 4805 0
Stock Exchange Tower, 800 Victoria Place (Suite 1700), PO Box 120, Montreal
Country [1] 4805 0
Primary sponsor type
Sydney South Western Area Health Service (SSWAHS)
Concord Repatriation General Hospital, Hospital Raod, Concord, NSW 2139
Secondary sponsor category [1] 4338 0
Name [1] 4338 0
Address [1] 4338 0
Country [1] 4338 0
Other collaborator category [1] 645 0
Government body
Name [1] 645 0
Australian Sports Drug Testing Laboratory (ASDTL)
Address [1] 645 0
1 Suakin Street, Pymble, NSW 2073
Country [1] 645 0

Ethics approval
Ethics application status
Ethics committee name [1] 6852 0
Concord Hospital Hospital Research Ethics Committee
Ethics committee address [1] 6852 0
Concord Hospital, Hospital Road, Concord, NSW 2139
Ethics committee country [1] 6852 0
Date submitted for ethics approval [1] 6852 0
Approval date [1] 6852 0
Ethics approval number [1] 6852 0
08/CRGH/106 CH62/6/2008-82

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29505 0
Address 29505 0
Country 29505 0
Phone 29505 0
Fax 29505 0
Email 29505 0
Contact person for public queries
Name 12752 0
D J Handelsman
Address 12752 0
Anzac Research Institute, Hospital Road, Concord, NSW 2139
Country 12752 0
Phone 12752 0
00612 9767 222
Fax 12752 0
00612 9767 7221
Email 12752 0
Contact person for scientific queries
Name 3680 0
D J Handelsman
Address 3680 0
Anzac Research Institute, Hospital Road, Concord NSW 2139
Country 3680 0
Phone 3680 0
00612 9767 7222
Fax 3680 0
00612 9767 7221
Email 3680 0

No information has been provided regarding IPD availability
Summary results
No Results