CLINICAL-PHARMACOLOGY OF RECOMBINANT HUMAN LUTEINIZING-HORMONE - PARTI - PHARMACOKINETICS AFTER INTRAVENOUS ADMINISTRATION TO HEALTHY FEMALE VOLUNTEERS AND COMPARISON WITH URINARY HUMAN LUTEINIZING-HORMONE
Jy. Lecotonnec et al., CLINICAL-PHARMACOLOGY OF RECOMBINANT HUMAN LUTEINIZING-HORMONE - PARTI - PHARMACOKINETICS AFTER INTRAVENOUS ADMINISTRATION TO HEALTHY FEMALE VOLUNTEERS AND COMPARISON WITH URINARY HUMAN LUTEINIZING-HORMONE, Fertility and sterility, 69(2), 1998, pp. 189-194
Objective: To assess the pharmacokinetics after IV administration of a
recombinant human LH and to compare them to those of a reference hMG
preparation containing urinary human LH. Design: Prospective, dose-esc
alating, cross-over study. Setting: Phase I clinical research environm
ent. Patient(s): Twelve healthy pituitary down-regulated females. Inte
rvention(s): Subjects received single TV doses of 300, 10,000, and 40,
000 IU of recombinant human LH, followed by a single IV dose of 300 IU
of hMG, all separated by 1 week. Main Outcome Measure(s): Pharmacokin
etic parameters. Results: For both preparations, LH serum levels were
well described by similar biexponential models. The pharmacokinetics o
f recombinant human LH were linear over the 300 to 40,000 IU range. Af
ter a rapid distribution phase with an initial half-life of 1 hour, bo
th recombinant human LH and urinary human LH were eliminated with a te
rminal half-life of 10-12 hours. Total serum clearance was 1.7 L/h wit
h <4% and 30% of the dose being eliminated in the urine for recombinan
t human LH and urinary human LH, respectively. The volume of distribut
ion at steady-state was approximately 10 L. Irrespective of the dose,
recombinant human LH was well tolerated. Conclusion(s): The pharmacoki
netics of recombinant human LH are linear with dose and similar to tho
se of urinary human LH. (C) 1998 by American Society for Reproductive
Medicine.