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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
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

Study type
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
Control group

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
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] 781 0
Name [1] 781 0
World Anti-Doping Agency
Address [1] 781 0
Country [1] 781 0
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
Country [2] 782 0
Primary sponsor type
St Vincent's Hospital Sydney Ltd
Darlinghurst, NSW
Secondary sponsor category [1] 646 0
Name [1] 646 0
Address [1] 646 0
Country [1] 646 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 2060 0
Approval date [1] 2060 0
Ethics approval number [1] 2060 0

Brief summary
Trial website
Trial related presentations / publications
Public notes

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
Phone 9697 0
+61 2 92958485
Fax 9697 0
+61 2 92958481
Email 9697 0
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
Phone 625 0
+61 2 92958489
Fax 625 0
+61 2 92958481
Email 625 0

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