Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000629235
Ethics application status
Not yet submitted
Date submitted
23/07/2009
Date registered
28/07/2009
Date last updated
28/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Detection of Indirect Androgen Doping with a GnRH Analog (Leuprolide)
Scientific title
Detection of gonadotrophin releasing hormone (GnRH) analog (Leuprolide) as a sports doping agent in healthy male volunteers aged 18 to 50. A randomised, open label, parallel group study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of GnRH analog injections on healthy males, as a sports doping agent. 237342 0
Condition category
Condition code
Metabolic and Endocrine 239664 239664 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of two groups.
Group 1 will receive daily subcutaneous injections of Lucrin 1mg for 4 days in week 1 (days 1 to 4) and again for 4 days in week 3 (days 15 to 18).
Group 2 will also receive daily subcutaneous injections of Lucirn 1mg for 4 days in week 1 (days 1 to 4) and again for 4 days in week 3 (days 15 to 18) as well as an intramuscular injection of nandrolone decanoate on day 12 (200mg) and day 17 (100mg).
Blood an urine samples will be collected each morning (except at weekends) from day 1 to day 24.
The overall duration of treatment is 24 days.
Intervention code [1] 237008 0
Treatment: Drugs
Comparator / control treatment
The group receiveing nandrolone will be compared with the the non nadrolone group. The baseline blood and urine samples from each participant will be compared with subsequent samples from the same participant.
Control group
Active

Outcomes
Primary outcome [1] 238443 0
To determine the hormonal effects of the administration of GnRH analog (Leuprolide) through the measurement of serum and urine luteinising hormone (LH) and testosterone (T) and urine testosterone/epitestosterone (T/E) ratio.
Timepoint [1] 238443 0
A single blood and urine sample will be collected from each participant at baseline and each morning on days 1 to 5, 8 to 12, 15 to 19 and 22 to 24.
Secondary outcome [1] 244948 0
To establish methods of detecting the use of illicit hormones (GnRH analogs) by elite athletes for sports doping.
Timepoint [1] 244948 0
All blood and urine samples collected during the study period will be analysed at the completion of the study.

Eligibility
Key inclusion criteria
Healthy men aged 18 to 50.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent history of steroid use/abuse

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)
Permutated block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237391 0
Government body
Name [1] 237391 0
World Anti Doping Agency (WADA) Pending
Country [1] 237391 0
Canada
Primary sponsor type
Hospital
Name
Sydney South West Area Health Authority (SSWAHS)
Address
Concord Repatriation General Hospital
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 236891 0
None
Name [1] 236891 0
Address [1] 236891 0
Country [1] 236891 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239523 0
Concord Hospital, Human Research Hthics Committee (HREC)
Ethics committee address [1] 239523 0
Concord Repatriation General Hospital, Hospital Road, Concord NSW 2139
Ethics committee country [1] 239523 0
Australia
Date submitted for ethics approval [1] 239523 0
21/07/2009
Approval date [1] 239523 0
Ethics approval number [1] 239523 0

Summary
Brief summary
Sports anti-doping study. The aim of this study is to see what effect injections of a synthetic hormone called a GnRH analog have on testosterone levels as measured in blood and urine samples. GnRH analogs are banned in elite sports as they are considered to enhance an athletes performance by increasing the body's production of testosterone. In this study blood and urine samples will be collected from healthy male volunteers before and after several injections of Lucrin (GnRH anaolg). Half of the volunteers (8) will be randomly assigned to also receive 2 injections of a drug called nandrolone decanoate. It is thought that nandrolone and GnRH analogs may be used in combination for ilicit sports doping.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29956 0
Address 29956 0
Country 29956 0
Phone 29956 0
Fax 29956 0
Email 29956 0
Contact person for public queries
Name 13203 0
D J Handelsman
Address 13203 0
Anzac Research Institute
Hospital Road
Concord NSW 2139
Country 13203 0
Australia
Phone 13203 0
00612 9767 7222
Fax 13203 0
00612 9767 7221
Email 13203 0
[email protected]
Contact person for scientific queries
Name 4131 0
D J Handelsman
Address 4131 0
Anzac Research Institute
Hospital Road
Concord NSW 2139
Country 4131 0
Australia
Phone 4131 0
00612 9767 7222
Fax 4131 0
00612 9767 7221
Email 4131 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
SourceTitleYear of PublicationDOI
EmbaseDMSO Assisted Electrospray Ionization for the Detection of Small Peptide Hormones in Urine by Dilute-and-Shoot-Liquid-Chromatography-High Resolution Mass Spectrometry.2017https://dx.doi.org/10.1007/s13361-017-1670-7
N.B. These documents automatically identified may not have been verified by the study sponsor.