Back to resultsCetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Primary Purpose
Benign Prostatic Hypertrophy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cetrorelix 78+78
Cetrorelix 78 + Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hypertrophy
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
Sites / Locations
- 19th Central Regional Policlinic, Urology department
- 4th City Hospital
- Minsk Regional Clinical Hospital, Clinic of Urology
- University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department
- Aleksandrovska Hospital, Kidney Transplantation Department
- Aleksandrovska Hospital, Oncourology Department
- National Central Hospital for Active Treatment of Oncology JSC
- Multiprofil Hospital "Sveta Anna", Urology Department
- Privat urological ambulance
- Health Center SANUS
- Privat urological ambulance
- Urocentrum Prague, Out-Patient Clinic of Urology
- Androgeos Clinic
- Policlinic Pod Marjánkou 12, Urological Department
- 1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology
- Urological center Uro-Santé Brumlovka
- Faculty hospital Na Bulovce
- Hopital Henri Mondor Service Urologie
- CHU Hôpital Claude Huriez
- Hopital Edouard Heriot Service Urologie
- Hopital René Dubos Service Urologie 6
- C.H.U Rangueil, Service d'Urologie
- Urologische Gemeinschaftspraxis Rulf/Langhorst
- Urologische Praxisgemeinschaft Frankfurt Höchst
- Pan-Klinik Urologie
- Urologische Praxis
- Urologische Praxis
- Urologische Klinik, Ev. Krankenhaus Oberhausen
- Klinikum Offenbach GmbH, Klinik für Urologie
- Asklepios Klinik Seligenstadt
- Praxis Filipas
- University of Bari, Department of Urology
- Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele
- Università Federico II Napoli
- Università Federico II Napoli
- University of Padova, Department of Urology
- Urology Clinic Skopje
- Gelre Ziekenhuizen
- Onze Lieve Vrouwe Gasthuis
- Andros Mannenkliniek
- Atrium Medisch Centrum
- Andros Mannenkliniek
- Andros Mannenkliniek
- Andros Mannenkliniek
- Canisius-Wilhelmina Ziekenhuis
- Streekziekenhuis Koningin Beatrix
- S.C. Uro Andro Med Srl
- Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie
- Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"
- Clinica Chirurgie Urologica si Transplant Renal
- Centrul Medical "Sf. Pantelimon"
- Leighton Hospital, Clinical Trials Dept., Michael Heal Unit
- Bristol Royal Infirmary, Urology Research Unit
- Leicester General Hospital, Urology Section
- Freeman Hospital, Urology Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Cetrorelix 78+78
Cetrorelix 78 + Placebo
Placebo
Arm Description
Outcomes
Primary Outcome Measures
International Prostate Symptom Score (IPSS)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00663858
Brief Title
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
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AEterna Zentaris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cetrorelix 78+78
Arm Type
Experimental
Arm Title
Cetrorelix 78 + Placebo
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cetrorelix 78+78
Intervention Description
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
Intervention Name(s)
Cetrorelix 78 + Placebo
Intervention Description
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo on Week 0, Week 2, Week 26 and Week 28
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Description
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)
Time Frame
Baseline and 52 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans MJ Debruyne, M.D.
Organizational Affiliation
Andros Mannenkliniek, Arnhem, The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
19th Central Regional Policlinic, Urology department
City
Minsk
ZIP/Postal Code
220 023
Country
Belarus
Facility Name
4th City Hospital
City
Minsk
ZIP/Postal Code
220 036
Country
Belarus
Facility Name
Minsk Regional Clinical Hospital, Clinic of Urology
City
Minsk
ZIP/Postal Code
223 052
Country
Belarus
Facility Name
University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Aleksandrovska Hospital, Kidney Transplantation Department
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Aleksandrovska Hospital, Oncourology Department
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
National Central Hospital for Active Treatment of Oncology JSC
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Multiprofil Hospital "Sveta Anna", Urology Department
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Privat urological ambulance
City
Besenov
ZIP/Postal Code
25601
Country
Czech Republic
Facility Name
Health Center SANUS
City
Hradec Králové
ZIP/Postal Code
500 02
Country
Czech Republic
Facility Name
Privat urological ambulance
City
Plzen
ZIP/Postal Code
323 26
Country
Czech Republic
Facility Name
Urocentrum Prague, Out-Patient Clinic of Urology
City
Prague
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Androgeos Clinic
City
Prague
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Policlinic Pod Marjánkou 12, Urological Department
City
Prague
ZIP/Postal Code
169 00
Country
Czech Republic
Facility Name
1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology
City
Praha
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Urological center Uro-Santé Brumlovka
City
Praha
ZIP/Postal Code
14000
Country
Czech Republic
Facility Name
Faculty hospital Na Bulovce
City
Praha
ZIP/Postal Code
18081
Country
Czech Republic
Facility Name
Hopital Henri Mondor Service Urologie
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Edouard Heriot Service Urologie
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hopital René Dubos Service Urologie 6
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
C.H.U Rangueil, Service d'Urologie
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Urologische Gemeinschaftspraxis Rulf/Langhorst
City
Erkrath
ZIP/Postal Code
40699
Country
Germany
Facility Name
Urologische Praxisgemeinschaft Frankfurt Höchst
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Pan-Klinik Urologie
City
Köln
ZIP/Postal Code
50667
Country
Germany
Facility Name
Urologische Praxis
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Urologische Praxis
City
Münster
ZIP/Postal Code
48143
Country
Germany
Facility Name
Urologische Klinik, Ev. Krankenhaus Oberhausen
City
Oberhausen
ZIP/Postal Code
46047
Country
Germany
Facility Name
Klinikum Offenbach GmbH, Klinik für Urologie
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Asklepios Klinik Seligenstadt
City
Seligenstadt
ZIP/Postal Code
63500
Country
Germany
Facility Name
Praxis Filipas
City
Wiesbaden
ZIP/Postal Code
65185
Country
Germany
Facility Name
University of Bari, Department of Urology
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Università Federico II Napoli
City
Naples
ZIP/Postal Code
80100
Country
Italy
Facility Name
Università Federico II Napoli
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
University of Padova, Department of Urology
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Urology Clinic Skopje
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Gelre Ziekenhuizen
City
Amsterdam
ZIP/Postal Code
1091
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091
Country
Netherlands
Facility Name
Andros Mannenkliniek
City
Arnhem
ZIP/Postal Code
6803 AA
Country
Netherlands
Facility Name
Atrium Medisch Centrum
City
Heerlen
ZIP/Postal Code
6401 CX
Country
Netherlands
Facility Name
Andros Mannenkliniek
City
Leiden
ZIP/Postal Code
2316
Country
Netherlands
Facility Name
Andros Mannenkliniek
City
Maastricht
ZIP/Postal Code
6212 XN
Country
Netherlands
Facility Name
Andros Mannenkliniek
City
Maastricht
ZIP/Postal Code
6212
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6500 GS
Country
Netherlands
Facility Name
Streekziekenhuis Koningin Beatrix
City
Winterswijk
ZIP/Postal Code
7101
Country
Netherlands
Facility Name
S.C. Uro Andro Med Srl
City
Bucharest
ZIP/Postal Code
021336
Country
Romania
Facility Name
Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie
City
Bucharest
ZIP/Postal Code
042122
Country
Romania
Facility Name
Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"
City
Bucharest
ZIP/Postal Code
050659
Country
Romania
Facility Name
Clinica Chirurgie Urologica si Transplant Renal
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
Centrul Medical "Sf. Pantelimon"
City
Pantelimon
ZIP/Postal Code
77145
Country
Romania
Facility Name
Leighton Hospital, Clinical Trials Dept., Michael Heal Unit
City
Crewe
State/Province
Cheshire
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Bristol Royal Infirmary, Urology Research Unit
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Leicester General Hospital, Urology Section
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Freeman Hospital, Urology Clinic
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7AA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
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