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

December 15, 2010 updated by: AEterna Zentaris

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220 023
        • 19th Central Regional Policlinic, Urology department
      • Minsk, Belarus, 220 036
        • 4th City Hospital
      • Minsk, Belarus, 223 052
        • Minsk Regional Clinical Hospital, Clinic of Urology
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department
      • Sofia, Bulgaria, 1431
        • Aleksandrovska Hospital, Kidney Transplantation Department
      • Sofia, Bulgaria, 1431
        • Aleksandrovska Hospital, Oncourology Department
      • Sofia, Bulgaria, 1756
        • National Central Hospital for Active Treatment of Oncology JSC
      • Varna, Bulgaria, 9000
        • Multiprofil Hospital "Sveta Anna", Urology Department
  • Czech Republic
      • Besenov, Czech Republic, 25601
        • Privat urological ambulance
      • Hradec Králové, Czech Republic, 500 02
        • Health Center SANUS
      • Plzen, Czech Republic, 323 26
        • Privat urological ambulance
      • Prague, Czech Republic, 120 00
        • Urocentrum Prague, Out-Patient Clinic of Urology
      • Prague, Czech Republic, 160 00
        • Androgeos Clinic
      • Prague, Czech Republic, 169 00
        • Policlinic Pod Marjánkou 12, Urological Department
      • Praha, Czech Republic, 12808
        • 1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology
      • Praha, Czech Republic, 14000
        • Urological center Uro-Santé Brumlovka
      • Praha, Czech Republic, 18081
        • Faculty hospital Na Bulovce
  • France
      • Creteil, France, 94000
        • Hopital Henri Mondor service Urologie
      • Lille, France, 59037
        • CHU Hôpital Claude Huriez
      • Lyon, France, 69437
        • Hopital Edouard Heriot Service Urologie
      • Pontoise, France, 95301
        • Hopital René Dubos Service Urologie 6
      • Toulouse, France, 31000
        • C.H.U Rangueil, Service d'Urologie
  • Germany
      • Erkrath, Germany, 40699
        • Urologische Gemeinschaftspraxis Rulf/Langhorst
      • Frankfurt, Germany, 65929
        • Urologische Praxisgemeinschaft Frankfurt Höchst
      • Köln, Germany, 50667
        • Pan-Klinik Urologie
      • Marburg, Germany, 35039
        • Urologische Praxis
      • Münster, Germany, 48143
        • Urologische Praxis
      • Oberhausen, Germany, 46047
        • Urologische Klinik, Ev. Krankenhaus Oberhausen
      • Offenbach, Germany, 63069
        • Klinikum Offenbach GmbH, Klinik für Urologie
      • Seligenstadt, Germany, 63500
        • Asklepios Klinik Seligenstadt
      • Wiesbaden, Germany, 65185
        • Praxis Filipas
  • Italy
      • Bari, Italy, 70124
        • University of Bari, Department of Urology
      • Milano, Italy, 20132
        • Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele
      • Naples, Italy, 80100
        • Università Federico II Napoli
      • Napoli, Italy, 80100
        • Università Federico II Napoli
      • Padova, Italy, 35128
        • University of Padova, Department of Urology
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Urology Clinic Skopje
  • Netherlands
      • Amsterdam, Netherlands, 1091
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands, 1091
        • Gelre Ziekenhuizen
      • Arnhem, Netherlands, 6803 AA
        • Andros Mannenkliniek
      • Heerlen, Netherlands, 6401 CX
        • Atrium medisch centrum
      • Leiden, Netherlands, 2316
        • Andros Mannenkliniek
      • Maastricht, Netherlands, 6212 XN
        • Andros Mannenkliniek
      • Maastricht, Netherlands, 6212
        • Andros Mannenkliniek
      • Nijmegen, Netherlands, 6500 GS
        • Canisius-Wilhelmina Ziekenhuis
      • Winterswijk, Netherlands, 7101
        • Streekziekenhuis Koningin Beatrix
  • Romania
      • Bucharest, Romania, 021336
        • S.C. Uro Andro Med Srl
      • Bucharest, Romania, 042122
        • Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie
      • Bucharest, Romania, 050659
        • Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"
      • Bucharest, Romania, 22328
        • Clinica Chirurgie Urologica si Transplant Renal
      • Pantelimon, Romania, 77145
        • Centrul Medical "Sf. Pantelimon"
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary, Urology Research Unit
      • Leicester, United Kingdom, LE5 4PW
        • Leicester General Hospital, Urology Section
      • Newcastle upon Tyne, United Kingdom, NE7 7AA
        • Freeman Hospital, Urology Clinic
    • Cheshire
      • Crewe, Cheshire, United Kingdom, CW1 4QJ
        • Leighton Hospital, Clinical Trials Dept., Michael Heal Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo on Week 0, Week 2, Week 26 and Week 28
Experimental: Cetrorelix 78+78
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)
Experimental: Cetrorelix 78 + Placebo
Drug: Cetrorelix 78 + Placebo
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: 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)
Baseline and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AEterna Zentaris

Investigators

  • Study Chair: Frans MJ Debruyne, M.D., Andros Mannenkliniek, Arnhem, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

January 17, 2011

Last Update Submitted That Met QC Criteria

December 15, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEZS-102-036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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