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Trial registered on ANZCTR


Registration number
ACTRN12605000508673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
26/09/2005
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Defining interactions between anabolic and peptide hormones: requirement for a robust test for growth hormone doping.
Scientific title
Defining interactions between anabolic and peptide hormones: requirement for a robust test for growth hormone doping.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjects are healthy volunteers. No medical condition is being studied. 633 0
Condition category
Condition code
Metabolic and Endocrine 705 705 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, markers of growth hormone (GH) doping will be measured in healthy volunteers in response to administration of GH and/or testosterone. Healthy male and female recreationally trained athletes will be randomised to growth hormone/placebo. The duration of intervention with GH is for 8 weeks in total. For the first 3 weeks, the dose of GH will be increased in a step-wise manner then maintained at the final dose for 5 weeks. Males will also be treated with testosterone/placebo for the last 5 weeks, in addition to GH/placebo. After the treatment period there will be further 6 weeks follow up.
Intervention code [1] 508 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 858 0
Measurements of biochemical markers of GH in blood samples collected throughout the treatment and wash-out phases
Timepoint [1] 858 0
Measured when all subjects have completed the study.
Secondary outcome [1] 1721 0
The secondary outcomes are measurements of body composition and performance and assessment by questionnaire of mood state.
Timepoint [1] 1721 0
Measured as subjects participate in the protocol
Secondary outcome [2] 1722 0
Other novel markers of GH doping in blood and in urine will be investigated in samples after all the subjects have completed the study.
Timepoint [2] 1722 0
Measured at some time after all subjects have completed the study

Eligibility
Key inclusion criteria
1. Regular participation in at least 2 exercise sessions/week for at least 1 year.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Athletes who participate in competition at the state or national level or higher 2. Subjects who have taken any performance-enhancing drug previously (assessed by self reporting) 3. Pregnancy 4. Diabetes mellitus 5. History of cardiovascular, hepatic or renal disease 6. Known cancer.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation is concealed by the use of numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation was prepared by a computer-generated randomization list, in which the treatments have been randomly allocated in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 781 0
Charities/Societies/Foundations
Name [1] 781 0
World Anti-Doping Agency
Address [1] 781 0
Montreal
Country [1] 781 0
Canada
Funding source category [2] 782 0
Government body
Name [2] 782 0
Australian Government Department of Communications, Information Technology and the Arts
Address [2] 782 0
Canberra
Country [2] 782 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney Ltd
Address
Darlinghurst, NSW
Country
Australia
Secondary sponsor category [1] 646 0
None
Name [1] 646 0
Nil
Address [1] 646 0
Country [1] 646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2060 0
St Vincent's Hospital Sydney
Ethics committee address [1] 2060 0
Darlinghurst, NSW
Ethics committee country [1] 2060 0
Australia
Date submitted for ethics approval [1] 2060 0
Approval date [1] 2060 0
Ethics approval number [1] 2060 0

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

Contacts
Principal investigator
Name 36353 0
Address 36353 0
Country 36353 0
Phone 36353 0
Fax 36353 0
Email 36353 0
Contact person for public queries
Name 9697 0
Professor Ken Ho
Address 9697 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst NSW 2010
Country 9697 0
Australia
Phone 9697 0
+61 2 92958485
Fax 9697 0
+61 2 92958481
Email 9697 0
K.Ho@garvan.org.au
Contact person for scientific queries
Name 625 0
Dr Anne Nelson
Address 625 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst NSW 2010
Country 625 0
Australia
Phone 625 0
+61 2 92958489
Fax 625 0
+61 2 92958481
Email 625 0
a.nelson@garvan.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary