drugset / Trial / NCT00449150

Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

NCT00449150

Phase 3 Terminated 667 enrolled AEterna Zentaris
RandomizedParallel-groupDouble-blindTreatment

Summary

Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement. For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

Timeline

Start
2007-03
Primary completion
2009-06
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetrorelix Other / unclassified 52 mg Intramuscular
Subject Cetrorelix Other / unclassified 78 mg Intramuscular