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

AEterna Zentaris

Status and phase: Terminated; Phase 3

Conditions: Benign Prostatic Hypertrophy

Treatments: Drug: Cetrorelix 78 mg + 78 mg; Drug: Cetrorelix 78 mg + 52 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449150

Z033

Details and patient eligibility

About

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).

Full 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.

Enrollment: 667 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Benign Prostatic Hyperplasia, based on medical history
• Voiding symptoms

Exclusion criteria

• Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder
• Major organ dysfunction
• Eczema (atopic dermatitis) treated during the last 6 months
• Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization
• Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
• History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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667 participants in 3 patient groups, including a placebo group

Treatment Group A: CET 78 mg + 78 mg

Experimental group

Description:

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.

Treatment:

Drug: Cetrorelix 78 mg + 78 mg

Treatment Group B: CET 78 mg + 52 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Cetrorelix 78 mg + 52 mg

Treatment Group C: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo