Pharmacokinetics of two human menopausal gonadotrophin preparations after single intravenous administration during pituitary suppression

A randomized study was performed in nine healthy women, to investigate pharmacokinetic parameters and bioequivalence of two human menopausal gonadotrophin preparations after i.v. administration. Endogenous gonadotrophin activity was suppressed by triptorelin administration. Humegon and Pergonal (225...

Full description

Saved in:
Bibliographic Details
Published inHuman reproduction (Oxford) Vol. 10; no. 6; p. 1367
Main Authors Duijkers, I J, Beerens, M C, Coelingh Bennink, H J, Huisman, J A, Rombout, F, Vemer, H M
Format Journal Article
LanguageEnglish
Published England 01.06.1995
Subjects
Adolescent
Adult
Analysis of Variance
Chorionic Gonadotropin - pharmacology
Cross-Over Studies
Depression, Chemical
Female
Fluoroimmunoassay
Follicle Stimulating Hormone - pharmacology
Humans
Injections, Intravenous
Luteinizing Hormone - pharmacology
Menotropins - administration & dosage
Menotropins - pharmacokinetics
Pituitary Gland - drug effects
Reference Values
Therapeutic Equivalency
Online AccessGet more information

Cover

More Information
Summary:A randomized study was performed in nine healthy women, to investigate pharmacokinetic parameters and bioequivalence of two human menopausal gonadotrophin preparations after i.v. administration. Endogenous gonadotrophin activity was suppressed by triptorelin administration. Humegon and Pergonal (225 IU of each) were injected i.v. in a cross-over way with an interval of 1 week. Blood samples were collected frequently and serum concentrations of follicle stimulating hormone (FSH), luteinizing hormone (LH), specific LH, and human chorionic gonadotrophin (HCG) were determined by fluoroimmunoassays assays. Serum LH bioactivity was measured by an in-vitro bioassay. The area under curve (AUC) and half-life of FSH were respectively 431.5 IU h/l and 22.20 h for Humegon, and 402.6 IU h/l and 21.33 h for Pergonal. For both preparations, the (total) LH immunoactivity and in-vitro bioactivity of serum LH were very similar, and appeared to be a composite of specific LH and HCG activity. The AUC data of specific LH were 17.50 IU h/l for Humegon and 21.79 IU h/l for Pergonal respectively. The AUC and half-life of HCG were 153.7 IU h/l and 14.80 h for Humegon, and 134.1 IU h/l and 12.11 h for Pergonal. The two preparations were bioequivalent with respect to FSH and HCG immunoreactivity. Bioequivalence could not be proven for LH activity because of the small number of subjects.
ISSN:0268-1161
1460-2350