Benign Prostatic Hypertrophy Clinical Trial
Official title:
Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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