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

Phase 3

Completed

• Conditions: Benign Prostatic Hypertrophy
• Interventions: Drug: Cetrorelix 78+78; Drug: Cetrorelix 78 + Placebo; Other: Placebo

• Registration Number: NCT00663858
• Lead Sponsor: AEterna Zentaris

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

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-22
• Primary Completion: 2009-09
• Study Completion: 2010-01
• Results First Submitted: 2010-11-11
• Status Verified: 2010-12
• Results First Submitted QC: 2010-12-15
• Last Update Submitted: 2010-12-15
• Results First Posted: 2011-01-17
• Last Update Posted: 2011-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cetrorelix 78+78	Cetrorelix 78+78	-
Cetrorelix 78 + Placebo	Cetrorelix 78 + Placebo	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)	Baseline and 52 weeks	IPSS score of BPH symptoms 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 overall score range: 0 points (best) to 35 points (worst)

Trial Locations

Locations (49)

19th Central Regional Policlinic, Urology department; 🇧🇾 Minsk, Belarus

4th City Hospital; 🇧🇾 Minsk, Belarus

Minsk Regional Clinical Hospital, Clinic of Urology; 🇧🇾 Minsk, Belarus

University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department; 🇧🇬 Plovdiv, Bulgaria

Aleksandrovska Hospital, Kidney Transplantation Department; 🇧🇬 Sofia, Bulgaria

Aleksandrovska Hospital, Oncourology Department; 🇧🇬 Sofia, Bulgaria

National Central Hospital for Active Treatment of Oncology JSC; 🇧🇬 Sofia, Bulgaria

Multiprofil Hospital "Sveta Anna", Urology Department; 🇧🇬 Varna, Bulgaria

Privat urological ambulance; 🇨🇿 Plzen, Czech Republic

Health Center SANUS; 🇨🇿 Hradec Králové, Czech Republic

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