Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000300279
Ethics application status
Approved
Date submitted
17/04/2009
Date registered
19/05/2009
Date last updated
5/07/2012
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

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

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
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)
Country [1] 4805 0
Canada
Primary sponsor type
Hospital
Name
Sydney South Western Area Health Service (SSWAHS)
Address
Concord Repatriation General Hospital, Hospital Raod, Concord, NSW 2139
Country
Australia
Secondary sponsor category [1] 4338 0
None
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
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 6852 0
30/06/2008
Approval date [1] 6852 0
23/10/2008
Ethics approval number [1] 6852 0
08/CRGH/106 CH62/6/2008-82

Summary
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

Contacts
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
Australia
Phone 12752 0
00612 9767 222
Fax 12752 0
00612 9767 7221
Email 12752 0
djh@anzac.edu.au
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
Australia
Phone 3680 0
00612 9767 7222
Fax 3680 0
00612 9767 7221
Email 3680 0
djh@anzac.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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