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

Inclusion Criteria1

  • Healthy males over the age of 18

Exclusion Criteria4

  • 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

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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