RecruitingPhase 4ACTRN12621001053819

Pharmacokinetics of Recombinant and Urinary Human Chorionic Gonadotrophin

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.


Sponsor

Sydney Local Health District

Enrollment

10 participants

Start Date

May 3, 2022

Study Type

Interventional

Conditions

Summary

This research study will evaluate and update the efficiency of an old and new form of test to detect hCG in blood for an antidoping setting.


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 56 Yearss

Plain Language Summary

Simplified for easier understanding

Human chorionic gonadotrophin (hCG) is a hormone that is naturally produced in the body, but it is also misused by some athletes as a performance-enhancing substance. Anti-doping authorities test athletes for hCG to catch this misuse. However, the tests need to distinguish between natural hCG levels and artificially elevated ones, which is complicated. This study will compare two forms of hCG — one derived from human urine and one produced using recombinant (laboratory) technology — to understand how each is processed by the body over time. Healthy male participants will receive an injection of one form of hCG, and blood samples will be collected at various time points to track how the hormone behaves. This study is open to healthy males aged 18 to 56. You must have no history of chronic illness, male infertility, steroid use, or known allergy to hCG. The goal of the research is to help improve anti-doping detection methods, not to treat any medical condition.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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/

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


Locations(1)

Concord Repatriation Hospital - Concord

NSW, Australia

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ACTRN12621001053819