Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
- Conditions
- Benign Prostatic Hypertrophy
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 420
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
- 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
4th City Hospital
🇧🇾Minsk, Belarus
Privat urological ambulance
🇨🇿Plzen, Czech Republic
1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology
🇨🇿Praha, Czech Republic
Minsk Regional Clinical Hospital, Clinic of Urology
🇧🇾Minsk, Belarus
Urocentrum Prague, Out-Patient Clinic of Urology
🇨🇿Prague, Czech Republic
Policlinic Pod Marjánkou 12, Urological Department
🇨🇿Prague, Czech Republic
Faculty hospital Na Bulovce
🇨🇿Praha, Czech Republic
University of Bari, Department of Urology
🇮🇹Bari, Italy
Hopital Edouard Heriot Service Urologie
🇫🇷Lyon, France
National Central Hospital for Active Treatment of Oncology JSC
🇧🇬Sofia, Bulgaria
Aleksandrovska Hospital, Kidney Transplantation Department
🇧🇬Sofia, Bulgaria
Urologische Praxisgemeinschaft Frankfurt Höchst
🇩🇪Frankfurt, Germany
Multiprofil Hospital "Sveta Anna", Urology Department
🇧🇬Varna, Bulgaria
Klinikum Offenbach GmbH, Klinik für Urologie
🇩🇪Offenbach, Germany
Hopital René Dubos Service Urologie 6
🇫🇷Pontoise, France
Università Federico II Napoli
🇮🇹Napoli, Italy
Urologische Gemeinschaftspraxis Rulf/Langhorst
🇩🇪Erkrath, Germany
Androgeos Clinic
🇨🇿Prague, Czech Republic
19th Central Regional Policlinic, Urology department
🇧🇾Minsk, Belarus
Urological center Uro-Santé Brumlovka
🇨🇿Praha, Czech Republic
Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele
🇮🇹Milano, Italy
University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department
🇧🇬Plovdiv, Bulgaria
CHU Hôpital Claude Huriez
🇫🇷Lille, France
Urologische Praxis
🇩🇪Münster, Germany
Health Center SANUS
🇨🇿Hradec Králové, Czech Republic
Atrium Medisch Centrum
🇳🇱Heerlen, Netherlands
Hopital Henri Mondor Service Urologie
🇫🇷Creteil, France
Pan-Klinik Urologie
🇩🇪Köln, Germany
Asklepios Klinik Seligenstadt
🇩🇪Seligenstadt, Germany
Urology Clinic Skopje
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Streekziekenhuis Koningin Beatrix
🇳🇱Winterswijk, Netherlands
Leicester General Hospital, Urology Section
🇬🇧Leicester, United Kingdom
Aleksandrovska Hospital, Oncourology Department
🇧🇬Sofia, Bulgaria
Praxis Filipas
🇩🇪Wiesbaden, Germany
C.H.U Rangueil, Service d'Urologie
🇫🇷Toulouse, France
University of Padova, Department of Urology
🇮🇹Padova, Italy
Canisius-Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Andros Mannenkliniek
🇳🇱Maastricht, Netherlands
Gelre Ziekenhuizen
🇳🇱Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
S.C. Uro Andro Med Srl
🇷🇴Bucharest, Romania
Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"
🇷🇴Bucharest, Romania
Centrul Medical "Sf. Pantelimon"
🇷🇴Pantelimon, Romania
Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie
🇷🇴Bucharest, Romania
Clinica Chirurgie Urologica si Transplant Renal
🇷🇴Bucharest, Romania
Leighton Hospital, Clinical Trials Dept., Michael Heal Unit
🇬🇧Crewe, Cheshire, United Kingdom
Bristol Royal Infirmary, Urology Research Unit
🇬🇧Bristol, United Kingdom
Urologische Klinik, Ev. Krankenhaus Oberhausen
🇩🇪Oberhausen, Germany
Freeman Hospital, Urology Clinic
🇬🇧Newcastle upon Tyne, United Kingdom