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Fertil Steril ; 81(2): 297-304, 2004 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-14967363

RESUMO

OBJECTIVE: The present study aims at demonstrating the equivalence of the 28-day and 3-month formulations of triptorelin SR (sustained release) in terms of percentage of patients achieving castration levels of estradiol (<==50 pg/mL) 84 days after treatment initiation. DESIGN: A phase II, prospective, randomized, multicenter, open study was conducted in two parallel groups of women with endometriosis. SETTING: Academic hospitals. PATIENT(S): Seventy-two women with endometriosis. were treated with a single intramuscular injection of 3-month triptorelin SR, and 74 patients were treated with one intramuscular injection of 28-day triptorelin SR every 28 days for 3 months. INTERVENTION(S): As part of two parallel treatment groups, 72 women were given a single intramuscular injection of 3-month triptorelin SR, and 74 women were given one intramuscular injection of 28-day triptorelin SR every 28 days for 3 months. MAIN OUTCOME MEASURE(S): Percentage of patients achieving castration levels of estradiol at the end of the treatment period. RESULT(S): Patients participated in the study until resumption of menses. Ninety-seven percent of patients given the 3-month formulation and 94% of those given the 28-day formulation were in a state of medical castration on day 84. The mean time to achieve castration was shorter for the 3-month formulation, and the duration of castration was significantly longer. The FSH and LH parameters were comparable, though not always identical. CONCLUSION(S): The pharmacodynamic effects of the Decapeptyl SR 3-month formulation are equivalent to those of the 28-day formulation. The 3-month formulation provides the added advantage of a longer maintenance of medical castration in women who have endometriosis.


Assuntos
Endometriose/tratamento farmacológico , Pamoato de Triptorrelina/uso terapêutico , Adulto , Química Farmacêutica , Esquema de Medicação , Estradiol/sangue , Feminino , Hormônio Foliculoestimulante/sangue , Humanos , Injeções Intramusculares , Hormônio Luteinizante/sangue , Luteolíticos/efeitos adversos , Luteolíticos/uso terapêutico , Recidiva , Fatores de Tempo , Pamoato de Triptorrelina/administração & dosagem , Pamoato de Triptorrelina/efeitos adversos
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