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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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

Study type
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

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.

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

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment status
Not yet recruiting
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] 237391 0
Government body
Name [1] 237391 0
World Anti Doping Agency (WADA) Pending
Address [1] 237391 0
Stock Exchange Tower, 800 Victoria Place
(Suite 1700) PO Box 120 Montreal, Quebec
H4Z 1B7
Country [1] 237391 0
Primary sponsor type
Sydney South West Area Health Authority (SSWAHS)
Concord Repatriation General Hospital
Concord NSW 2139
Secondary sponsor category [1] 236891 0
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
Date submitted for ethics approval [1] 239523 0
Approval date [1] 239523 0
Ethics approval number [1] 239523 0

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

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
Phone 13203 0
00612 9767 7222
Fax 13203 0
00612 9767 7221
Email 13203 0
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
Phone 4131 0
00612 9767 7222
Fax 4131 0
00612 9767 7221
Email 4131 0

No information has been provided regarding IPD availability
Summary results
No Results