Pharmacokinetics of Recombinant and Urinary Human Chorionic Gonadotrophin

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: 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 CONDITION: Other ‐ Research that is not of generic health relevance and not applicable to specific health categories listed above Pharmacological study in healthy individuals to improve a sports anti‐doping test; ; Pharmacological study in healthy individuals to improve a sports anti‐doping test PRIMARY OUTCOME: Time course of serum and urine hCG concentrations [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: Nil[Nil] INCLUSION CRITERIA: Healthy males over the age of 18
Epistemonikos ID: 2ea324ceb30324b0f3b4e69543199c2ba428f354
First added on: Aug 25, 2024