Clinical trial NCT00663858: Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Official title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hypertrophy
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 420
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: Baseline and 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: 19th Central Regional Policlinic, Urology department
city: Minsk
country: Belarus
facility: 4th City Hospital
city: Minsk
country: Belarus
facility: Minsk Regional Clinical Hospital, Clinic of Urology
city: Plovdiv
country: Bulgaria
facility: University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department
city: Sofia
country: Bulgaria
facility: Aleksandrovska Hospital, Kidney Transplantation Department
city: Sofia
country: Bulgaria
facility: Aleksandrovska Hospital, Oncourology Department
city: Sofia
country: Bulgaria
facility: National Central Hospital for Active Treatment of Oncology JSC
city: Varna
country: Bulgaria
facility: Multiprofil Hospital "Sveta Anna", Urology Department
city: Besenov
country: Czech Republic
facility: Privat urological ambulance
city: Hradec Králové
country: Czech Republic
facility: Health Center SANUS
city: Plzen
country: Czech Republic
facility: Privat urological ambulance
city: Prague
country: Czech Republic
facility: Urocentrum Prague, Out-Patient Clinic of Urology
city: Prague
country: Czech Republic
facility: Androgeos Clinic
city: Prague
country: Czech Republic
facility: Policlinic Pod Marjánkou 12, Urological Department
city: Praha
country: Czech Republic
facility: 1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology
city: Praha
country: Czech Republic
facility: Urological center Uro-Santé Brumlovka
city: Praha
country: Czech Republic
facility: Faculty hospital Na Bulovce
city: Creteil
country: France
facility: Hopital Henri Mondor Service Urologie
city: Lille
country: France
facility: CHU Hôpital Claude Huriez
city: Lyon
country: France
facility: Hopital Edouard Heriot Service Urologie
city: Pontoise
country: France
facility: Hopital René Dubos Service Urologie 6
city: Toulouse
country: France
facility: C.H.U Rangueil, Service d'Urologie
city: Erkrath
country: Germany
facility: Urologische Gemeinschaftspraxis Rulf/Langhorst
city: Frankfurt
country: Germany
facility: Urologische Praxisgemeinschaft Frankfurt Höchst
city: Köln
country: Germany
facility: Pan-Klinik Urologie
city: Marburg
country: Germany
facility: Urologische Praxis
city: Münster
country: Germany
facility: Urologische Praxis
city: Oberhausen
country: Germany
facility: Urologische Klinik, Ev. Krankenhaus Oberhausen
city: Offenbach
country: Germany
facility: Klinikum Offenbach GmbH, Klinik für Urologie
city: Seligenstadt
country: Germany
facility: Asklepios Klinik Seligenstadt
city: Wiesbaden
country: Germany
facility: Praxis Filipas
city: Bari
country: Italy
facility: University of Bari, Department of Urology
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele
city: Naples
country: Italy
facility: Università Federico II Napoli
city: Napoli
country: Italy
facility: Università Federico II Napoli
city: Padova
country: Italy
facility: University of Padova, Department of Urology
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Urology Clinic Skopje
city: Amsterdam
country: Netherlands
facility: Gelre Ziekenhuizen
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Arnhem
country: Netherlands
facility: Andros Mannenkliniek
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
city: Leiden
country: Netherlands
facility: Andros Mannenkliniek
city: Maastricht
country: Netherlands
facility: Andros Mannenkliniek
city: Maastricht
country: Netherlands
facility: Andros Mannenkliniek
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Winterswijk
country: Netherlands
facility: Streekziekenhuis Koningin Beatrix
city: Bucharest
country: Romania
facility: S.C. Uro Andro Med Srl
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"
city: Bucharest
country: Romania
facility: Clinica Chirurgie Urologica si Transplant Renal
city: Pantelimon
country: Romania
facility: Centrul Medical "Sf. Pantelimon"
city: Crewe
country: United Kingdom
facility: Leighton Hospital, Clinical Trials Dept., Michael Heal Unit
state: Cheshire
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary, Urology Research Unit
city: Leicester
country: United Kingdom
facility: Leicester General Hospital, Urology Section
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital, Urology Clinic
Study officials:
affiliation: Andros Mannenkliniek, Arnhem, The Netherlands
name: Frans MJ Debruyne, M.D.
role: STUDY_CHAIR
References: