| Pharmacokinetic and pharmacodynamic interactions between recombinant human luteinizing hormone and recombinant human follicle-stimulating hormone. | |
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MedLine Citation:
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PMID: 9496329 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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J Y le Cotonnec; E Loumaye; H C Porchet; V Beltrami; A Munafo |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Fertility and sterility Volume: 69 ISSN: 0015-0282 ISO Abbreviation: Fertil. Steril. Publication Date: 1998 Feb |
Date Detail:
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Created Date: 1998-03-24 Completed Date: 1998-03-24 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0372772 Medline TA: Fertil Steril Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 201-9 Citation Subset: IM |
Affiliation:
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Serono International S.A., Geneva, Switzerland. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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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