Conditions: Benign Prostatic Hypertrophy
Keywords: Cetrorelix
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 667
Healthy volunteers: no

Brief 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).

Detailed description:
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.

Arms:
arm 1: Treatment course 1: Cetrorelix 78 mg + 78 mg

* Week 0: 52 mg CET (2 injections)
* Week 2: 26 mg CET (1 injection)

Treatment course 2:

* Week 26: 52 mg CET (2 injections)
* Week 28: 26 mg CET(1 injection)

  4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient. arm 2: Treatment course 1: Cetrorelix 78 mg + 52 mg

* Week 0: 52 mg CET (2 injections)
* Week 2: 26 mg CET (1 injection)

Treatment course 2:

* Week 26: 52 mg CET (2 injections)
* Week 28: Placebo (1 injection)

  4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient. arm 3: Treatment course 1:

* Week 0: placebo (2 injections)
* Week 2: placebo (1 injection)

Treatment course 2:

* Week 26: placebo (2 injections)
* Week 28: placebo (1 injection)

  4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.

Interventions: intervention 1: Cetrorelix 78 mg + 78 mg intervention 2: Cetrorelix 78 mg + 52 mg intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: