Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000189224
Ethics application status
Approved
Date submitted
26/02/2009
Date registered
17/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of gonadotropin releasing hormone (GnRH) analogs as doping or masking agents
Scientific title
Detection of gonadotropin releasing hormone (GnRH) analogs as a sports doping agent in healthy male volunteers aged 18 to 50. An open label, randomised, placebo controlled clinical study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Detection of gonadotropin relaeasing hormone (GnRH) analogs in healthy males, as a sports doping agent. 4558 0
Condition category
Condition code
Metabolic and Endocrine 4866 4866 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Particpants will be randomly allocated to one of four treatment groups.
Group 1 will receive daily subcutaneous (s/c) injections of saline (placebo) for 4 days.
Group 2 will receive daily s/c injections of superactive GnRH analog (Lucrin 1mg) for 4 days.
Group 3 will receive daily s/c injections of Lucrin 1mg for 4 days and concurrent administration of 100mg injectable testosterone (T) esters to supress endogenous leutenising hormone (LH) and T production.
Group 4 will receive daily s/c injections of Lucrin 1mg for 4 days and concurrent administration of nandrolone decanoate 100mg to supress endogenous LH and T production.
Blood and urine samples will be collected from all particpants at intervals from 0 for up to 14 days.
Intervention code [1] 4321 0
Treatment: Drugs
Comparator / control treatment
Group 1 (placebo group) will receive s/c saline injection in place of s/c Lucrin.
All particpants will provide baseline blood and urine samples to measure against post treatment samples.
Control group
Placebo

Outcomes
Primary outcome [1] 5705 0
To determine the hormonal effects of a supercative GnRH analog on the hormonal markers used in sports doping ie serum and urine LH and testosterone, and on the urinary testosterone/epitestosterone (T/E) ratio.
Timepoint [1] 5705 0
Samples of blood and urine will be collected at baseline and daily for up to 14 days.
Secondary outcome [1] 241620 0
To develop a detection test for this GnRH analog to be used in sports doping laboratories.
Timepoint [1] 241620 0
GnRH analog detection test will be developed following the collection of all study samples.

Eligibility
Key inclusion criteria
Healthy males
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent history of steroid 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
Randomised
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
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4747 0
Government body
Name [1] 4747 0
World Anti-Doping Agency (WADA) Pending
Country [1] 4747 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] 4287 0
None
Name [1] 4287 0
Address [1] 4287 0
Country [1] 4287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6787 0
Concord Hospital HREC
Ethics committee address [1] 6787 0
CRGH
Hospital Road
Concord NSW 2139
Ethics committee country [1] 6787 0
Australia
Date submitted for ethics approval [1] 6787 0
30/06/2008
Approval date [1] 6787 0
29/09/2008
Ethics approval number [1] 6787 0
8/CRGH/105

Summary
Brief summary
Sports anti-doping study. The aim of this study is to see what effects on testosterone an injection of a synthetic hormone called GnRH analog has. GnRH analogs are banned in elite sports as they are considered to enhance an athletes performance by increasing the bodies production of testosterone. In this study blood and urine specimens will be collected from healthy male volunteers who have been given several injections a GnRH analog. Some of the volunteers will also be given an injection of testosterone or a drug called nandrolone. These three drugs are all banned in elite athletes, but it is thought that they may be being used in combination illicitly.
Some of the volunteers will recieve injections of saline only given as a placebo, this allows us to compare the results with those of the volunteers receiving the drugs.
The blood and urine samples taken from the volunteers (before and after the injections) will be analysed to see what effects they have on hormone levels, and will be used to help develop a test to detect the use of GnRH anaolgs by elite athletes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29328 0
Address 29328 0
Country 29328 0
Phone 29328 0
Fax 29328 0
Email 29328 0
Contact person for public queries
Name 12575 0
D J Handelsman
Address 12575 0
Anzac Research Institute
Hospital Road
Concord NSW 2137
Country 12575 0
Australia
Phone 12575 0
+612 9767 7222
Fax 12575 0
+612 9767 7221
Email 12575 0
[email protected]
Contact person for scientific queries
Name 3503 0
D J Handelsman
Address 3503 0
Anzac Research Institute
Hospital Road
Concord NSW 2137
Country 3503 0
Australia
Phone 3503 0
+612 9767 7222
Fax 3503 0
+612 9767 7221
Email 3503 0
[email protected]

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.