Benign Prostatic Hypertrophy Clinical Trial
Official title:
Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment
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).
The objectives of the study are to develop a safe and tolerable intermittent dosage regimen
of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.
Patients will enter a 4-week run-in no-treatment observation period to confirm severity and
stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).
Patients will then be allocated to study drug in a double-blind, randomized, double-dummy,
placebo-controlled fashion.
Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will
be followed up to Week 52.
Then, in an open label fashion, patients will be administered an IM injection of study drug
at Week 52, 54, 78 and 80 and will be followed up to Week 90.
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