Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001053819
Ethics application status
Approved
Date submitted
8/06/2021
Date registered
10/08/2021
Date last updated
12/07/2022
Date data sharing statement initially provided
10/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of Recombinant and Urinary Human Chorionic Gonadotrophin
Scientific title
Pharmacokinetics of recombinant (r-hCG) versus urinary (u-hCG) human chorionic gonadotrophin with an emphasis on profiling effect of the WADA's anti doping tests.
Secondary ID [1] 304284 0
None
Universal Trial Number (UTN)
U1111-1267-0762
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacological study in healthy individuals to improve a sports anti-doping test 322017 0
Condition category
Condition code
Other 319761 319761 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of Recombinant human Chorionic Gonadotrophin (250 micrograms, r-hCG, Ovidrel, MerckSerono, Australia, ARTG 96037) and Urinary human chorionic gonadotrophin (5000 IU, u-hCG, Pregnyl, Merck/Schering Plough/Organon, Australia; ARTG 14518). Two phase cross over open and unblinded treatment. Subcutaneous injections are given by trained registered nurses in a hospital setting.
The drugs are given at 2 week intervals without a specific washout period but the drug effects lasts about a week (varies betwene individuals) and is not critical in this study. Just need samples from men exposed to both
Intervention code [1] 320701 0
Treatment: Drugs
Comparator / control treatment
Cross-over study so both drugs are compared to each other
Control group
Active

Outcomes
Primary outcome [1] 327688 0
Time course of serum and urine hCG concentrations
Timepoint [1] 327688 0
Three before treatment visits for blood and urine sampling within a week followed by treatment A or B (depending of randomization) than blood and urine sampling daily for a week post treatment then the following week on Monday, Wednesday, Friday with last post injection sample on Wednesday the week after. Cross over of treatment A or B and blood and urine sampling the same sequence as for the previous injection.
Secondary outcome [1] 396241 0
Nil
Timepoint [1] 396241 0
Nil

Eligibility
Key inclusion criteria
Healthy males over the age of 18
Minimum age
18 Years
Maximum age
56 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of any chronic disease or condition requiring regular medical management
History of male infertility or pituitary-testicular dysfunction
History of androgen (anabolic steroid) use or abuse
Allergic or other severe adverse reaction to hCG injections or their ingredients

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)
Simple randomization by computer with sequence numbers sealed in opaque envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Data will be analysed by standard methods for cross-over studies considering carry-over and sequence effects using NCSS software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
3/05/2022
Date of last participant enrolment
Anticipated
10/08/2022
Actual
Date of last data collection
Anticipated
10/08/2022
Actual
Sample size
Target
10
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19595 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 34286 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 308659 0
Government body
Name [1] 308659 0
Sydney Local Health District
Country [1] 308659 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Sydney Local Health District
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 309538 0
None
Name [1] 309538 0
Address [1] 309538 0
Country [1] 309538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308586 0
Sydney Local Health District Research Ethics Committee-Concord Repatriation General Hospital
Ethics committee address [1] 308586 0
Ethics committee country [1] 308586 0
Australia
Date submitted for ethics approval [1] 308586 0
22/02/2021
Approval date [1] 308586 0
28/05/2021
Ethics approval number [1] 308586 0
2021/ETH00427

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

Contacts
Principal investigator
Name 111234 0
Prof David Handelsman
Address 111234 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A Hospital Road
Concord 2139 NSW
Country 111234 0
Australia
Phone 111234 0
+61 2 9767 7222
Fax 111234 0
+61 2 9767 7221
Email 111234 0
djh@anzac.edu.au
Contact person for public queries
Name 111235 0
David Handelsman
Address 111235 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A Hospital Road
Concord 2139 NSW
Country 111235 0
Australia
Phone 111235 0
+61 297677222
Fax 111235 0
+61297677221
Email 111235 0
djh@anzac.edu.au
Contact person for scientific queries
Name 111236 0
David Handelsman
Address 111236 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A Hospital Road
Concord 2139 NSW
Country 111236 0
Australia
Phone 111236 0
+61 297677222
Fax 111236 0
+61297677221
Email 111236 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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.