Human Reproduction, Vol 13, 1461-1464, Copyright © 1998 by Oxford University Press
BM Mannaerts, TB Geurts and J Odink
The objective of this study was to compare the bioavailability of s.c. and
i.m. administration of human chorionic gonadotrophin (HCG; Pregnyl). In a
randomized, single-centre, three-way cross-over study, 18 healthy
pituitary-suppressed volunteers were assigned to single HCG injections of
5000 and 10,000 IU i.m. and 10,000 IU s.c. Rate (Cmax, t(max)) and extent
[area under curve from zero to infinity (AUC(0- infinity))] of absorption
of HCG were determined. Serum immunoactive HCG increased from 0.4-0.5 IU/l
at baseline to mean peak concentrations, which were reached 20 h after
injection of 156 IU/l with 5000 IU i.m., of 307 IU/l with 10,000 IU i.m.
and of 339 IU/l with 10,000 IU s.c. Eight days after administration, <
10% of the maximum HCG activity was found for each regimen. The elimination
half-life (t(1/2)) was on average 32-33 h, irrespective of the treatment
regimen. Intramuscular and s.c. injections of 10,000 IU HCG were
bioequivalent with respect to AUC(0-infinity). The Cmax and t(max) were
also similar between the two administration routes but bioequivalence could
not be proven due to intersubject variability. Intramuscular doses of 5000
IU and 10,000 IU HCG were dose-proportional. Since s.c. HCG is
bioequivalent to i.m. HCG with respect to extent of absorption (its major
pharmacokinetic variable) and is well tolerated, the s.c. administration
route may be effectively and safely used in assisted reproduction.
Moreover, since s.c. injection can be performed by the patients themselves,
acceptability may be enhanced.
ARTICLES
A randomized three-way cross-over study in healthy pituitary-suppressed women to compare the bioavailability of human chorionic gonadotrophin (Pregnyl) after intramuscular and subcutaneous administration
Clinical Development Department, NV Organon, Oss, The Netherlands.
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