Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000181303
Ethics application status
Approved
Date submitted
2/07/2007
Date registered
10/04/2008
Date last updated
8/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of recombinant human luteinising hormone (rLH) as a doping agent
Scientific title
Detection of recombinant human luteinising hormone as a doping agent in healthy male volunteers aged 18 to 45. An open label, randomised clinical study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports doping detection 2173 0
Condition category
Condition code
Metabolic and Endocrine 3176 3176 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Half of the participants will have a 200mg injection of Nandrolone decanoate, then 3 days later a single dose of rLH
75IU or 225IU or recombinant human chorionic gonadotropin 'rhCG' 250ug or 750ug . Those given 'rhCG' will have another 100mg dose of Nandrolone decanoate the following day. The other half of the participants will be given either a single dose of either rLH 75IU or 225IU or rhCG 250ug or 750ug without the Nandrolone. Blood and urine samples will be obtained at intervals form 0 for up to 8 days.
Intervention code [1] 2767 0
Treatment: Drugs
Comparator / control treatment
Acting as their own controls, baseline blood and urine samples taken to measure against post treatment samples.
Control group
Active

Outcomes
Primary outcome [1] 4061 0
Bioassay measurement of LH levels in blood and urine samples
Timepoint [1] 4061 0
Samples of blood and urine taken at baseline and at intervals for 8 days
Primary outcome [2] 4062 0
Bioassay measurement of testosterone in blood and urine samples
Timepoint [2] 4062 0
Samples of blood and urine taken at baseline and at intervals for 8 days
Secondary outcome [1] 6833 0
None
Timepoint [1] 6833 0
Not applicable

Eligibility
Key inclusion criteria
Healthy males
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
No recent history of steriod use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
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
Recruiting
Date of first participant enrolment
Anticipated
23/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 819 0
2139

Funding & Sponsors
Funding source category [1] 3280 0
Government body
Name [1] 3280 0
World Anti Doping Agency (WADA)
Country [1] 3280 0
Canada
Primary sponsor type
Hospital
Name
Sydney South Western Area Health Service (SSWAHS)
Address
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 2933 0
None
Name [1] 2933 0
Address [1] 2933 0
Country [1] 2933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4285 0
Concord Hospital HREC
Ethics committee address [1] 4285 0
Ethics committee country [1] 4285 0
Australia
Date submitted for ethics approval [1] 4285 0
Approval date [1] 4285 0
Ethics approval number [1] 4285 0
CH62/6/2004-110-D Handelsman
Ethics committee name [2] 5267 0
Concord Repatriation General Hospital (CRGH)
Ethics committee address [2] 5267 0
Ethics committee country [2] 5267 0
Australia
Date submitted for ethics approval [2] 5267 0
02/11/2004
Approval date [2] 5267 0
24/02/2005
Ethics approval number [2] 5267 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27681 0
Address 27681 0
Country 27681 0
Phone 27681 0
Fax 27681 0
Email 27681 0
Contact person for public queries
Name 11056 0
D J Handelsman
Address 11056 0
Anzac Research Institute
Hospital Road
Concord NSW 2139
Country 11056 0
Australia
Phone 11056 0
02 9767 7222
Fax 11056 0
02 9767 7221
Email 11056 0
djh@anzac.edu.au
Contact person for scientific queries
Name 1984 0
D J Handelsman
Address 1984 0
Anzac Research Institute
Hospital Road
Concord NSW 2139
Country 1984 0
Australia
Phone 1984 0
02 9767 7222
Fax 1984 0
02 9767 7221
Email 1984 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.