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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.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001053819
Enrollment
7
Registered
2021-08-10
Start date
2022-05-03
Completion date
2022-08-10
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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/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

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

Sponsors

Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to 56 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy males over the age of 18

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026