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

NCT00663858 | Completed Phase 3 Results DMC

• 1 other identifier: AEZS-102-036
• Study Type: interventional
• Target: 420
• Locations: 10 countries
• Sites: 55

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).

Conditions

Benign Prostatic Hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Cetrorelix 78+78

EXPERIMENTAL

Drug: Cetrorelix 78+78

Cetrorelix 78 + Placebo

EXPERIMENTAL

Drug: Cetrorelix 78 + Placebo

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Cetrorelix 78+78 DRUG

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+78

Cetrorelix 78 + Placebo DRUG

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

Cetrorelix 78 + Placebo

Placebo OTHER

Placebo on Week 0, Week 2, Week 26 and Week 28

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Benign Prostatic Hyperplasia, based on medical history
• Voiding symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• AEterna Zentaris: lead

Study Sites (55)

19th Central Regional Policlinic, Urology department

Minsk, 220 023, Belarus

Location

4th City Hospital

Minsk, 220 036, Belarus

Location

Minsk Regional Clinical Hospital, Clinic of Urology

Minsk, 223 052, Belarus

Location

University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department

Plovdiv, 4000, Bulgaria

Location

Aleksandrovska Hospital, Kidney Transplantation Department

Sofia, 1431, Bulgaria

Location

Aleksandrovska Hospital, Oncourology Department

Sofia, 1431, Bulgaria

Location

National Central Hospital for Active Treatment of Oncology JSC

Sofia, 1756, Bulgaria

Location

Multiprofil Hospital "Sveta Anna", Urology Department

Varna, 9000, Bulgaria

Location

Privat urological ambulance

Besenov, 25601, Czechia

Location

Health Center SANUS

Hradec Králové, 500 02, Czechia

Location

Privat urological ambulance

Pilsen, 323 26, Czechia

Location

Urocentrum Prague, Out-Patient Clinic of Urology

Prague, 120 00, Czechia

Location

1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology

Prague, 12808, Czechia

Location

Urological center Uro-Santé Brumlovka

Prague, 14000, Czechia

Location

Androgeos Clinic

Prague, 160 00, Czechia

Location

Policlinic Pod Marjánkou 12, Urological Department

Prague, 169 00, Czechia

Location

Faculty hospital Na Bulovce

Prague, 18081, Czechia

Location

Hopital Henri Mondor Service Urologie

Créteil, 94000, France

Location

CHU Hôpital Claude Huriez

Lille, 59037, France

Location

Hopital Edouard Heriot Service Urologie

Lyon, 69437, France

Location

Hopital René Dubos Service Urologie 6

Pontoise, 95301, France

Location

C.H.U Rangueil, Service d'Urologie

Toulouse, 31000, France

Location

Pan-Klinik Urologie

Cologne, 50667, Germany

Location

Urologische Gemeinschaftspraxis Rulf/Langhorst

Erkrath, 40699, Germany

Location

Urologische Praxisgemeinschaft Frankfurt Höchst

Frankfurt, 65929, Germany

Location

Urologische Praxis

Marburg, 35039, Germany

Location

Urologische Praxis

Münster, 48143, Germany

Location

Urologische Klinik, Ev. Krankenhaus Oberhausen

Oberhausen, 46047, Germany

Location

Klinikum Offenbach GmbH, Klinik für Urologie

Offenbach, 63069, Germany

Location

Asklepios Klinik Seligenstadt

Seligenstadt, 63500, Germany

Location

Praxis Filipas

Wiesbaden, 65185, Germany

Location

University of Bari, Department of Urology

Bari, 70124, Italy

Location

Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele

Milan, 20132, Italy

Location

Università Federico II Napoli

Naples, 80100, Italy

Location

Università Federico II Napoli

Napoli, 80100, Italy

Location

University of Padova, Department of Urology

Padua, 35128, Italy

Location

Gelre Ziekenhuizen

Amsterdam, 1091, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091, Netherlands

Location

Andros Mannenkliniek

Arnhem, 6803 AA, Netherlands

Location

Atrium Medisch Centrum

Heerlen, 6401 CX, Netherlands

Location

Andros Mannenkliniek

Leiden, 2316, Netherlands

Location

Andros Mannenkliniek

Maastricht, 6212 XN, Netherlands

Location

Andros Mannenkliniek

Maastricht, 6212, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, 6500 GS, Netherlands

Location

Streekziekenhuis Koningin Beatrix

Winterswijk, 7101, Netherlands

Location

Urology Clinic Skopje

Skopje, 1000, North Macedonia

Location

S.C. Uro Andro Med Srl

Bucharest, 021336, Romania

Location

Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie

Bucharest, 042122, Romania

Location

Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"

Bucharest, 050659, Romania

Location

Clinica Chirurgie Urologica si Transplant Renal

Bucharest, 22328, Romania

Location

Centrul Medical "Sf. Pantelimon"

Pantelimon, 77145, Romania

Location

Leighton Hospital, Clinical Trials Dept., Michael Heal Unit

Crewe, Cheshire, CW1 4QJ, United Kingdom

Location

Bristol Royal Infirmary, Urology Research Unit

Bristol, BS2 8HW, United Kingdom

Location

Leicester General Hospital, Urology Section

Leicester, LE5 4PW, United Kingdom

Location

Freeman Hospital, Urology Clinic

Newcastle upon Tyne, NE7 7AA, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Herbert Sindermann
• Organization: Aeterna Zentaris

HSindermann@aezsinc.com

+49 69 42602 3429

Study Officials

• Frans MJ Debruyne, M.D.

  Andros Mannenkliniek, Arnhem, The Netherlands

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 22, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2010
• Last Updated: January 17, 2011
• Results First Posted: January 17, 2011

Record last verified: 2010-12

Locations

RO (5); BU (5); FR (5); DE (9); CZ (9); BE (3); IT (5); GB (4); NL (9); NO (1)