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

NCT00449150 | Terminated Phase 3 Results

• 1 other identifier: Z033
• Study Type: interventional
• Target: 667
• Locations: 4 countries
• Sites: 68

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

Keywords

Cetrorelix

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptoms Score (IPSS)

  The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated 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 range: 0 points (best) to 35 points (worst)

  Baseline and 52 weeks

Secondary Outcomes (1)

• Time Course of Quality of Life

  Quality of life assessment in the following weeks: 4,12,26,30,38,46,52

Study Arms (3)

Treatment Group A: CET 78 mg + 78 mg

EXPERIMENTAL

Treatment course 1: Cetrorelix 78 mg + 78 mg * Week 0: 52 mg CET (2 injections) * Week 2: 26 mg CET (1 injection) Treatment course 2: * Week 26: 52 mg CET (2 injections) * Week 28: 26 mg CET(1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.

Drug: Cetrorelix 78 mg + 78 mg

Treatment Group B: CET 78 mg + 52 mg

EXPERIMENTAL

Treatment course 1: Cetrorelix 78 mg + 52 mg * Week 0: 52 mg CET (2 injections) * Week 2: 26 mg CET (1 injection) Treatment course 2: * Week 26: 52 mg CET (2 injections) * Week 28: Placebo (1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.

Drug: Cetrorelix 78 mg + 52 mg; Drug: Placebo

Treatment Group C: Placebo

PLACEBO COMPARATOR

Treatment course 1: * Week 0: placebo (2 injections) * Week 2: placebo (1 injection) Treatment course 2: * Week 26: placebo (2 injections) * Week 28: placebo (1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.

Drug: Placebo

Interventions

Cetrorelix 78 mg + 78 mg DRUG

Also known as: CET, AEZS-102

Treatment Group A: CET 78 mg + 78 mg

Cetrorelix 78 mg + 52 mg DRUG

Also known as: CET, AEZS-102

Treatment Group B: CET 78 mg + 52 mg

Placebo DRUG

Also known as: Placebo (PLA)

Treatment Group B: CET 78 mg + 52 mg; Treatment Group C: 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 (68)

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Urology Group of Westrn Arkansas

Fort Smith, Arkansas, 72901, United States

Location

South Orange County Medical Research Center

Laguna Hills, California, 92653, United States

Location

California Professionnal Research

Newport Beach, California, 92660, United States

Location

William G. Moseley

San Diego, California, 92103, United States

Location

West Coast Clinical Research

Tarzana, California, 91356, United States

Location

Western Clinical Research, Inc.

Torrance, California, 90505, United States

Location

Urology Research Options

Aurora, Colorado, 80012, United States

Location

Urologic Oncology

Aurora, Colorado, 80045-0510, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, 80220, United States

Location

Connecticut Clincal Research Center

Middlebury, Connecticut, 06762, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Atlantic Urological Associates

Daytona Beach, Florida, 32114, United States

Location

Miami VACM

Miami, Florida, 33125-1693, United States

Location

Florida Healthcare Research

Ocala, Florida, 34474, United States

Location

Florida Urologist Specialists

Sarasota, Florida, 34237, United States

Location

Southeastern Research Group

Tallahassee, Florida, 32308, United States

Location

Southwestern Medical Research Institute

Columbus, Georgia, 31904, United States

Location

Northwestern University Feinberg School of Medecine

Chicago, Illinois, 60611, United States

Location

Welborn Clinic

Evansville, Indiana, 47713, United States

Location

Northeast Indiana Research, LLC

Fort Wayne, Indiana, 46825, United States

Location

Kansas City Urology Care

Overland Park, Kansas, 66211, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

Myron I. Murdock M.D. LLC

Greenbelt, Maryland, 20770, United States

Location

Michigan Institute of Urology

Saint Clair Shores, Michigan, 48081, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Metropolitan Urological Specialists

St Louis, Missouri, 63136, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Delaware Valley Urology, LLC

Woodlane, New Jersey, 08060, United States

Location

Urology Group Of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Medical & Clinical Research Associates

Bay Shore, New York, 11706, United States

Location

Urological Surgeons of Long Island, Clinical Research Division

Garden City, New York, 11530, United States

Location

New York University School of Medecine

New York, New York, 10016, United States

Location

University Urology

New York, New York, 10016, United States

Location

Hudson Valley Urology

Poughkeepsie, New York, 12601, United States

Location

Northeast Urology Research

Concord, North Carolina, 28025, United States

Location

Parkhurst Research Oganization Inc.

Bethany, Oklahoma, 73008, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Vanderbilt University medical Center

Nashville, Tennessee, 37232, United States

Location

Corpus Christi Urology Group

Corpus Christi, Texas, 78404, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

University of Texas Southwestern Medical Center, Department of Urology

Dallas, Texas, 75390-9110, United States

Location

Institute and the Texas Prostate Center

Houston, Texas, 77030, United States

Location

Urology San Antonio Research, PA

San Antonio, Texas, 78229, United States

Location

Integrity Medical Research

Mountlake Terrace, Washington, 98043, United States

Location

National Oncological Hospital

Sofia, 1756, Bulgaria

Location

Southern Interior Medical Research Inc.

Kelowna, British Columbia, V1Y 2H4, Canada

Location

Andreou Research Inc.

Surrey, British Columbia, V3V 1N1, Canada

Location

Can-Med Clinical Reserach Inc.

Victoria, British Columbia, V8T 5G1, Canada

Location

The Male / FemaleHealth and Research Center

Barrie, Ontario, L4M 7G1, Canada

Location

Centre for Advanced Urological Research

Kingston, Ontario, K7L 3J7, Canada

Location

Urologic Associates, Urologic Medical Research

Kitchener, Ontario, N2M 5N4, Canada

Location

Canada Place Building

North Bay, Ontario, P1B 7K8, Canada

Location

The Fe/Male Health Centers

Oakville, Ontario, L6H 3P1, Canada

Location

University Health Network Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

The Male Health Center

Toronto, Ontario, M6A 3B5, Canada

Location

Urology South Shore Research

Greenfield Park, Quebec, J4V 2H3, Canada

Location

CHUM, Hopital St-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Dynamik Research

Pointe-Claire, Quebec, H9R 3J1, Canada

Location

CRCEO

Québec, Quebec, G1R 2J6, Canada

Location

ClinPharm International GmbH Prufzentrum Berlin

Berlin, 12627, Germany

Location

ClinPharm International GmbH Prufzentrum Bochum

Bochum, 44787, Germany

Location

ClinPharm International GmbH Prufzentrum Dresden

Dresden, 01067, Germany

Location

ClinPharm International GmbH Prufzentrum Frankfurt

Frankfurt, 60596, Germany

Location

ClinPharm International GmbH Prufzentrum Gorlitz

Görlitz, 02826, Germany

Location

ClinPharm International GmbH Prufzentrum Leipzig

Leipzig, 04103, Germany

Location

ClinPharm International GmbH Prufzentrum Magdeburg

Magdeburg, 39104, Germany

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Daniel Croteau, Medical Manager
• Organization: AEterna Zentaris

DCroteau@aezsinc.com

418-652-7669

Study Officials

• Dr. Hebert Lepor, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 3, 2018
• Results First Posted: January 19, 2011

Record last verified: 2011-06

Locations

US (46); CA (14); BU (1); DE (7)