Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: a Phase III, open-label, international multicenter study.
Clin Ther
; 32(4): 744-57, 2010 Apr.
Article
em En
| MEDLINE
| ID: mdl-20435244
ABSTRACT
BACKGROUND:
A microencapsulated, sustained-release formulation of leuprolide acetate 3.75 mg has been developed.OBJECTIVE:
This study investigated the effectiveness, pharmacokinetics, and safety profile of a 1-month leuprolide acetate 3.75-mg depot formulation for suppressing testosterone concentrations in patients with prostate cancer.METHODS:
This was a Phase III, open-label, international multicenter clinical trial. Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot. Plasma testosterone concentrations were determined at specific times throughout the study. The primary end point was the proportion of successful patients over the total number of evaluable patients (ie, patients with evaluable testosterone concentrations at all monthly assessments and no missing values due to treatment-related adverse events). Treatment success was defined as testosterone suppression below the clinical castration level (ie,CONCLUSIONS:
Leuprolide acetate 3.75-mg depot was effective in achieving and maintaining testosterone suppression and was well tolerated throughout the study in this cohort of patients with prostate cancer. ClinicalTrials.gov identifier NCT00128531.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Próstata
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Testosterona
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Leuprolida
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Antineoplásicos Hormonais
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Aged
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Aged80
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Clin Ther
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Áustria