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

NCT ID: NCT00663858

Last Updated: 2011-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-01-31

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).

Conditions

Benign Prostatic Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cetrorelix 78+78

Group Type: EXPERIMENTAL

Cetrorelix 78+78

Intervention Type: DRUG

Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)

Cetrorelix 78 + Placebo

Group Type: EXPERIMENTAL

Cetrorelix 78 + Placebo

Intervention Type: DRUG

Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo on Week 0, Week 2, Week 26 and Week 28

Interventions

Cetrorelix 78+78

Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)

Intervention Type: DRUG

Cetrorelix 78 + Placebo

Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28

Intervention Type: DRUG

Placebo

Placebo on Week 0, Week 2, Week 26 and Week 28

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AEterna Zentaris

INDUSTRY

Sponsor Role: lead

Principal Investigators

Frans MJ Debruyne, M.D.

Role: STUDY_CHAIR

Andros Mannenkliniek, Arnhem, The Netherlands

Locations

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

Besenov, , Czechia

Health Center SANUS

Hradec Králové, , Czechia

Privat urological ambulance

Pilsen, , Czechia

Urocentrum Prague, Out-Patient Clinic of Urology

Prague, , Czechia

1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology

Prague, , Czechia

Urological center Uro-Santé Brumlovka

Prague, , Czechia

Androgeos Clinic

Prague, , Czechia

Policlinic Pod Marjánkou 12, Urological Department

Prague, , Czechia

Faculty hospital Na Bulovce

Prague, , Czechia

Hopital Henri Mondor Service Urologie

Créteil, , France

CHU Hôpital Claude Huriez

Lille, , France

Hopital Edouard Heriot Service Urologie

Lyon, , France

Hopital René Dubos Service Urologie 6

Pontoise, , France

C.H.U Rangueil, Service d'Urologie

Toulouse, , France

Pan-Klinik Urologie

Cologne, , Germany

Urologische Gemeinschaftspraxis Rulf/Langhorst

Erkrath, , Germany

Urologische Praxisgemeinschaft Frankfurt Höchst

Frankfurt, , Germany

Urologische Praxis

Marburg, , Germany

Urologische Praxis

Münster, , Germany

Urologische Klinik, Ev. Krankenhaus Oberhausen

Oberhausen, , Germany

Klinikum Offenbach GmbH, Klinik für Urologie

Offenbach, , Germany

Asklepios Klinik Seligenstadt

Seligenstadt, , Germany

Praxis Filipas

Wiesbaden, , Germany

University of Bari, Department of Urology

Bari, , Italy

Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele

Milan, , Italy

Università Federico II Napoli

Naples, , Italy

Università Federico II Napoli

Napoli, , Italy

University of Padova, Department of Urology

Padua, , Italy

Gelre Ziekenhuizen

Amsterdam, , Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Andros Mannenkliniek

Arnhem, , Netherlands

Atrium Medisch Centrum

Heerlen, , Netherlands

Andros Mannenkliniek

Leiden, , Netherlands

Andros Mannenkliniek

Maastricht, , Netherlands

Andros Mannenkliniek

Maastricht, , Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Streekziekenhuis Koningin Beatrix

Winterswijk, , Netherlands

Urology Clinic Skopje

Skopje, , North Macedonia

S.C. Uro Andro Med Srl

Bucharest, , Romania

Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie

Bucharest, , Romania

Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"

Bucharest, , Romania

Clinica Chirurgie Urologica si Transplant Renal

Bucharest, , Romania

Centrul Medical "Sf. Pantelimon"

Pantelimon, , Romania

Leighton Hospital, Clinical Trials Dept., Michael Heal Unit

Crewe, Cheshire, United Kingdom

Bristol Royal Infirmary, Urology Research Unit

Bristol, , United Kingdom

Leicester General Hospital, Urology Section

Leicester, , United Kingdom

Freeman Hospital, Urology Clinic

Newcastle upon Tyne, , United Kingdom

Countries

Belarus; Bulgaria; Czechia; France; Germany; Italy; Netherlands; North Macedonia; Romania; United Kingdom

Other Identifiers

AEZS-102-036

Identifier Type: -

Identifier Source: org_study_id