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Titolo:
Pharmacodynamic effects and plasma pharmacokinetics of single doses of cetrorelix acetate in healthy premenopausal women
Autore:
Erb, K; Klipping, C; Duijkers, I; Pechstein, B; Schueler, A; Hermann, R;
Indirizzi:
ASTA Medica AG, Clin Res & Dev, Frankfurt, Germany ASTA Medica AG Frankfurt Germany AG, Clin Res & Dev, Frankfurt, Germany Dinox Bv, Nijmegen, Netherlands Dinox Bv Nijmegen NetherlandsDinox Bv, Nijmegen, Netherlands
Titolo Testata:
FERTILITY AND STERILITY
fascicolo: 2, volume: 75, anno: 2001,
pagine: 316 - 323
SICI:
0015-0282(200102)75:2<316:PEAPPO>2.0.ZU;2-H
Fonte:
ISI
Lingua:
ENG
Soggetto:
GONADOTROPIN-RELEASING-HORMONE; GANIRELIX ANTAGON/ORGALUTRAN-ASTERISK; FOLLICLE-STIMULATING-HORMONE; ANTAGONIST CETRORELIX; LUTEINIZING-HORMONE; FEMALE VOLUNTEERS; OVARIAN STIMULATION; INJECTION; ANALOGS; GNRH;
Keywords:
GnRH; LHRH antagonist; cetrorelix acetate (Cetrotide); LH surge; ovulation; pharmacodynamics; pharmacokinetics; dose proportionality;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
21
Recensione:
Indirizzi per estratti:
Indirizzo: Erb, K Appl Clin Pharmacol Serv, Philippsring 11, D-55252 Mainz, Germany Appl Clin Pharmacol Serv Philippsring 11 Mainz Germany D-55252 any
Citazione:
K. Erb et al., "Pharmacodynamic effects and plasma pharmacokinetics of single doses of cetrorelix acetate in healthy premenopausal women", FERT STERIL, 75(2), 2001, pp. 316-323

Abstract

Objective: To investigate the pharmacodynamic effects and plasma pharmacokinetics of single subcutaneous doses of cetrorelix acetate in healthy premenopausal women. Setting: Phase I clinical research unit. Patient(s): Healthy, premenopausal women aged 19 to 35 years. Intervention(s): Single subcutaneous morning doses of cetrorelix acetate (1, 3, or 5 mg peptide base) were investigated in a randomized, single-blind, placebo-controlled, parallel-group design. After a control cycle, 36 women received cetrorelix acetate (12 per dose) and 12 received placebo on the eighth individual cycle day. Transvaginal ultrasound was performed, and blood samples for LH, FSH, E-2 were collected during both cycles and for pharmacokinetics up to 168 hours after dosing. The serum hormone levels were determined by electrochemicoluminescence immunoassay and plasma cetrorelix concentrations by radioimmuno assay. Results: Cetrorelix acetate administration led to a rapid, marked, and reversible suppression of serum LH, E-2, and to a lesser extent FSH concentrations. The median intra-individual shifts between treatment and control cycle were -1.0, 4.0, 8.0, and 9.5 days for serum LH maximum and -1.0, 4.5, 7.0, and 10.0 days for ovulation following placebo or 1, 3, and 5 rug cetrorelix acetate, peptide base, respectively. The area under the concentration-time curve (AUC) and peak cetrorelix concentrations in plasma (C-max) increased proportionally with dose. Conclusions: Cetrorelix acetate showed pronounced and reversible LH and E-2 suppression and a dose-dependent postponement of LH surge and ovulation after single subcutaneous administrations to healthy premenopausal women. Dose proportionality over the range of 1 mg to 5 mg cetrorelix acetate, peptide base was demonstrated. (Fertil Steril((R)) 2001;75:316-23. (C) 2001 by American Society for Reproductive Medicine.).

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 19/09/20 alle ore 09:20:31