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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment

Conditions
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Benign Prostatic Hypertrophy

Intervention / Treatment
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* Drug: Cetrorelix 78 mg + 78 mg
* Drug: Cetrorelix 78 mg + 52 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group A: CET 78 mg + 78 mg<br>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. | Drug: Cetrorelix 78 mg + 78 mg<br> <br> * Other names: AEZS-102;|
| Experimental: Treatment Group B: CET 78 mg + 52 mg<br>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. | Drug: Cetrorelix 78 mg + 52 mg<br> <br> * Other names: AEZS-102;Drug: Placebo<br> <br> * Other names: Placebo (PLA);|
| Placebo Comparator: Treatment Group C: Placebo<br>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. | Drug: Placebo<br> <br> * Other names: Placebo (PLA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptoms Score (IPSS) | The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst) | Baseline and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Course of Quality of Life | The time course of quality of life: assessed by the following disease specific quality of life:If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that? The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible. | Quality of life assessment in the following weeks: 4,12,26,30,38,46,52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cetrorelix