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Titolo:
Local tolerance, pharmacokinetics, and dynamics of ganirelix (Orgalutran (R)) administration by Medi-Jector (R) compared to conventional needle injections
Autore:
Oberye, J; Mannaerts, B; Huisman, J; Timmer, C;
Indirizzi:
NV Organon, Clin Dev Dept, Res & Dev, NL-5340 BH Oss, Netherlands NV Organon Oss Netherlands NL-5340 BH & Dev, NL-5340 BH Oss, Netherlands
Titolo Testata:
HUMAN REPRODUCTION
fascicolo: 2, volume: 15, anno: 2000,
pagine: 245 - 249
SICI:
0268-1161(200002)15:2<245:LTPADO>2.0.ZU;2-H
Fonte:
ISI
Lingua:
ENG
Soggetto:
GONADOTROPIN-RELEASING-HORMONE; HUMAN GROWTH-HORMONE; FOLLICLE-STIMULATING-HORMONE; ANTAGONIST CETRORELIX; JET-INJECTION; NORMAL MEN; PHARMACODYNAMICS; SERUM; SECRETION; SINGLE;
Keywords:
GnRH antagonist ganirelix; local tolerance; Medi-Jector (R); pharmacokinetics; pituitary hormones;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
18
Recensione:
Indirizzi per estratti:
Indirizzo: Oberye, J NV Organon, Clin Dev Dept, Res & Dev, POB 20, NL-5340 BH Oss, Netherlands NV Organon POB 20 Oss Netherlands NL-5340 BH H Oss, Netherlands
Citazione:
J. Oberye et al., "Local tolerance, pharmacokinetics, and dynamics of ganirelix (Orgalutran (R)) administration by Medi-Jector (R) compared to conventional needle injections", HUM REPR, 15(2), 2000, pp. 245-249

Abstract

The feasibility of administering a relatively high dose of the gonadotrophin-releasing hormone (GnRH) antagonist ganirelix by means of a needle-free injection device, which could be useful in the long-term treatment of sex-steroid-dependent disorders, was evaluated in a randomized, crossover study in 16 healthy females. Local tolerance and pharmacokinetics of ganirelix administered by Medi-Jector(R) versus conventional needle injections were compared. Additionally, the pharmacodynamic effect was evaluated. Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector(R) or conventional needle in a randomized sequence, without a washout period. No apparent differences in local tolerance were observed. Most injections (87.5%) gave either no or only a mild reaction. Of the moderate reactions, swelling and redness were reported most frequently (overall 4.9 and 8.5% per injection, respectively). Administration by Medi-Jector(R) was bioequivalent to conventional needle injection with respect to the peak concentration and area under the curve. A profound suppression of luteinizing hormone and follicle stimulating hormone was observed. Serum oestradiol and progesterone concentrations were relatively low prior to treatment and remained low during the entire study period. In conclusion, administration of a relatively high dose of ganirelix by Medi-Jector(R) might be useful for long-termtreatment of sex-steroid dependent disorders.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/09/20 alle ore 16:32:42