Document Detail


Pharmacokinetic and pharmacodynamic interactions between recombinant human luteinizing hormone and recombinant human follicle-stimulating hormone.
MedLine Citation:
PMID:  9496329     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To assess the pharmacokinetics of a recombinant human LH preparation and its pharmacokinetic and pharmacodynamic interactions with recombinant human follicle-stimulating hormone (FSH). DESIGN: Prospective, randomized cross-over study. SETTING: Phase I clinical research environment. PATIENT(S): Twelve healthy pituitary down-regulated females. INTERVENTION(S): Subjects received 150 IU of s.c. recombinant human LH and FSH, either alone or in combination, followed by recombinant human LH and FSH once daily for 7 days. MAIN OUTCOME MEASURE(S): Pharmacokinetic parameters, ovarian follicle development. RESULT(S): No pharmacokinetic interaction between recombinant human LH and FSH was observed, with no significant difference in baseline-corrected maximal observed concentration over baseline, area under the concentration-time curve from t = 0 to t = 24 hours, or time to maximal concentration after single doses alone or in combination. After daily administration, the mean accumulation ratio was 1.6 for LH and 2.9 for FSH, with absorption and terminal phase half-life estimates of 4 and 11 hours for LH and 8 and 16 hours for FSH, respectively. Combined administration of FSH and LH for 7 days was effective in stimulating ovarian follicular development and steroidogenesis, with large interindividual variability related to ovarian sensitivity. CONCLUSION(S): A new recombinant human LH preparation has a low accumulation ratio at steady-state and no pharmacokinetic or pharmacodynamic interactions with recombinant human FSH.
Authors:
J Y le Cotonnec; E Loumaye; H C Porchet; V Beltrami; A Munafo
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Fertility and sterility     Volume:  69     ISSN:  0015-0282     ISO Abbreviation:  Fertil. Steril.     Publication Date:  1998 Feb 
Date Detail:
Created Date:  1998-03-24     Completed Date:  1998-03-24     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0372772     Medline TA:  Fertil Steril     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  201-9     Citation Subset:  IM    
Affiliation:
Serono International S.A., Geneva, Switzerland.
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MeSH Terms
Descriptor/Qualifier:
Adult
Cross-Over Studies
Drug Combinations
Estradiol / blood,  metabolism
Female
Follicle Stimulating Hormone / administration & dosage,  pharmacokinetics*,  pharmacology
Gonadotropin-Releasing Hormone / analogs & derivatives
Goserelin / pharmacology
Half-Life
Humans
Inhibins / blood,  metabolism
Injections, Subcutaneous
Luteinizing Hormone / administration & dosage,  pharmacokinetics*,  pharmacology
Ovarian Follicle / drug effects
Pituitary Gland / drug effects
Prospective Studies
Recombinant Proteins / administration & dosage,  pharmacokinetics,  pharmacology
Time Factors
Chemical
Reg. No./Substance:
0/Drug Combinations; 0/Recombinant Proteins; 33515-09-2/Gonadotropin-Releasing Hormone; 50-28-2/Estradiol; 57285-09-3/Inhibins; 65807-02-5/Goserelin; 9002-67-9/Luteinizing Hormone; 9002-68-0/Follicle Stimulating Hormone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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