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

Benign Prostatic Hypertrophy Clinical Trial

Official title:

Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663858
• Other study ID #: AEZS-102-036
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2008
• Last updated: December 15, 2010
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: December 2010
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Romania: State Institute for Drug ControlBelarus: Ministry of HealthCzech Republic: State Institute for Drug ControlBulgaria: Ministry of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthFrance: Ministry of HealthMacedonia: Ethics CommitteeGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with a 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

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

Other:
• Placebo
Placebo on Week 0, Week 2, Week 26 and Week 28

Locations

Country	Name	City	State
Belarus	19th Central Regional Policlinic, Urology department	Minsk
Belarus	4th City Hospital	Minsk
Belarus	Minsk Regional Clinical Hospital, Clinic of Urology	Minsk
Bulgaria	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
Czech Republic	Privat urological ambulance	Besenov
Czech Republic	Health Center SANUS	Hradec Králové
Czech Republic	Privat urological ambulance	Plzen
Czech Republic	Androgeos Clinic	Prague
Czech Republic	Policlinic Pod Marjánkou 12, Urological Department	Prague
Czech Republic	Urocentrum Prague, Out-Patient Clinic of Urology	Prague
Czech Republic	1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology	Praha
Czech Republic	Faculty hospital Na Bulovce	Praha
Czech Republic	Urological center Uro-Santé Brumlovka	Praha
France	Hopital Henri Mondor Service Urologie	Creteil
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
Germany	Urologische Gemeinschaftspraxis Rulf/Langhorst	Erkrath
Germany	Urologische Praxisgemeinschaft Frankfurt Höchst	Frankfurt
Germany	Pan-Klinik Urologie	Köln
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
Italy	University of Bari, Department of Urology	Bari
Italy	Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele	Milano
Italy	Università Federico II Napoli	Naples
Italy	Università Federico II Napoli	Napoli
Italy	University of Padova, Department of Urology	Padova
Macedonia, The Former Yugoslav R	Urology Clinic Skopje	Skopje
Netherlands	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
Romania	Clinica Chirurgie Urologica si Transplant Renal	Bucharest
Romania	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	Centrul Medical "Sf. Pantelimon"	Pantelimon
United Kingdom	Bristol Royal Infirmary, Urology Research Unit	Bristol
United Kingdom	Leighton Hospital, Clinical Trials Dept., Michael Heal Unit	Crewe	Cheshire
United Kingdom	Leicester General Hospital, Urology Section	Leicester
United Kingdom	Freeman Hospital, Urology Clinic	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Countries where clinical trial is conducted

Belarus,  Bulgaria,  Czech Republic,  France,  Germany,  Italy,  Macedonia, The Former Yugoslav Republic of,  Netherlands,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and 52 weeks	No