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Trial registered on ANZCTR


Registration number
ACTRN12619001506189
Ethics application status
Approved
Date submitted
16/10/2019
Date registered
31/10/2019
Date last updated
31/10/2019
Date data sharing statement initially provided
31/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Detection of Testosterone Microdosing in Healthy Men
Scientific title
Detection of Testosterone Microdosing in Healthy Men with an emphasis on profiling effect of the WADA’s Athletes Biological Passport (ABP)
Secondary ID [1] 299559 0
None
Universal Trial Number (UTN)
U1111-1242-0783
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Doping in sports 314821 0
Condition category
Condition code
Metabolic and Endocrine 313163 313163 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekly intramuscular injection of 50mg (0.2ml) for three weeks of mixed testosterone esters -testosterone propionate 30mg, testosterone phenylpropionate 60mg, testosterone isocaproate 60mg, testosterone decanoate 100mg. Injections are given by trained registered nurses in a hospital setting.
Intervention code [1] 315816 0
Treatment: Drugs
Comparator / control treatment
No comparator or control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321689 0
Serum (LC-MS) and urine (GC-MSMS, GC-C-IRMS, LC-HRMS and immunoassay) and steroid, hematological and peptide hormone profiles before, during and after testosterone administration. This is exploratory descriptive composite outcome.
Timepoint [1] 321689 0
Before treatment visits (6 day visits within 3 weeks) will be set on Monday's and Thursday's) followed by 3 weeks of treatment and blood and urine sampling (treatment on Monday's of each week and blood and urine sampling on Monday's and Thursday's of each week). After treatment 12 more visits within 6 weeks on Monday's and Thursday's.
Secondary outcome [1] 375899 0
Dried blood spot, plasma and serum direct steroid analysis, serum LH and FSH and urine LH and hCG (immunoassay), UGT2B17 genotype, hematology (full blood count including reticulocyte count). This is exploratory descriptive composite outcome.
Timepoint [1] 375899 0
Before treatment visits (6 day visits within 3 weeks) will be set on Monday's and Thursday's) followed by 3 weeks of treatment and blood and urine sampling (treatment on Monday's of each week and blood and urine sampling on Monday's and Thursday's of each week). After treatment 12 more visits within 6 weeks on Monday's and Thursday's.

Eligibility
Key inclusion criteria
• Healthy men aged over 18 years of age
• Provide written, informed consent and willing to comply with all study requirements
Minimum age
18 Years
Maximum age
80 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Contraindications to testosterone administration (prostate or breast cancer, untreated sleep apnea or polycythemia)
• Allergy to peanuts
• Bleeding disorder or taking anti-coagulant drugs
• Major, serious or chronic medical disorders including chronic viral infections (HIV, hepatitis) requiring regular prescribed medication;
• Regular use of medications that interferes with metabolism of testosterone
• History of androgen or other drug abuse within last year
• Major psychiatric disease or psychological condition that limits understanding and compliance with study requirements in the opinion of the investigator
• Men in competitive sporting teams subject to WADA or other occupational drug testing that would disclose testosterone administration

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Mixed model linear analysis with serial repeated measurements of serum and urine steroids and hematological profile before, during and after testosterone treatment with age and body weight (or BMI) as covariates.
For analytes where there is a significant difference from baseline, linear discriminant analysis and receiver-operated curve(ROC) analysis will be used to define the optimal cutpoint( Youden's index) for individual and combined parameters to detect testosterone administration as well as the window of detection during run-off.
The findings will also be analyzed with ABP software for steroidal and hematological modules.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 14966 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 28252 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 304044 0
Government body
Name [1] 304044 0
National Measurement Institute
Address [1] 304044 0
105 Delhi Rd, North Ryde NSW 2113
Country [1] 304044 0
Australia
Primary sponsor type
Government body
Name
Sydney local Health District
Address
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 304235 0
None
Name [1] 304235 0
Address [1] 304235 0
Country [1] 304235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304535 0
Sydney Local Health District Research Ethics Committee-Concord Repatriation General Hospital
Ethics committee address [1] 304535 0
Building 20,
Concord Repatriation General Hospital,
1A Hospital Road,
Concord 2139 NSW
Ethics committee country [1] 304535 0
Australia
Date submitted for ethics approval [1] 304535 0
01/04/2019
Approval date [1] 304535 0
09/10/2019
Ethics approval number [1] 304535 0
2018/ETH00711

Summary
Brief summary
This study aims to determine the effectiveness (sensitivity and specificity) of individual serum and urine steroid, hematological and peptide hormone profiles within the Athletes Biological Passport to detect testosterone micro-dosing in men, and determine the applicability of venous and capillary blood analysis as complimentary testing procedures to those stated for the Athletes Biological Passport.
Furthermore, the data for individuals would be collated and evaluated to include legal planning and expert opinion as to how a case against a potentially doping athlete could be undertaken and what data would be required. This information would enable WADA laboratories to identify future testing requirements of samples to ensure all applicable data is available for the Athletes Biological Passport.
Trial website
N/A
Trial related presentations / publications
Nil yet
Public notes
N/A

Contacts
Principal investigator
Name 97302 0
Prof David Handelsman
Address 97302 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A Hospital Road
Concord 2139 NSW
Country 97302 0
Australia
Phone 97302 0
+61 297677222
Fax 97302 0
+61 297677221
Email 97302 0
djh@anzac.edu.au
Contact person for public queries
Name 97303 0
Prof David Handelsman
Address 97303 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A Hospital Road
Concord 2139 NSW
Country 97303 0
Australia
Phone 97303 0
+61 297677222
Fax 97303 0
+61 297677221
Email 97303 0
djh@anzac.edu.au
Contact person for scientific queries
Name 97304 0
Prof David Handelsman
Address 97304 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A Hospital Road
Concord 2139 NSW
Country 97304 0
Australia
Phone 97304 0
+61 297677222
Fax 97304 0
+61 297677221
Email 97304 0
djh@anzac.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results