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

NCT ID: NCT00449150

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 667 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-12-31

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).

Detailed Description

The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.

Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).

Patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.

Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.

Then, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 90.

Conditions

Benign Prostatic Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group A: CET 78 mg + 78 mg

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.

Group Type: EXPERIMENTAL

Cetrorelix 78 mg + 78 mg

Intervention Type: DRUG

Treatment Group B: CET 78 mg + 52 mg

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.

Group Type: EXPERIMENTAL

Cetrorelix 78 mg + 52 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Treatment Group C: Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Cetrorelix 78 mg + 78 mg

Intervention Type: DRUG

Cetrorelix 78 mg + 52 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

CET; AEZS-102; CET; AEZS-102; Placebo (PLA)

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AEterna Zentaris

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Hebert Lepor, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

Urology Group of Westrn Arkansas

Fort Smith, Arkansas, United States

South Orange County Medical Research Center

Laguna Hills, California, United States

California Professionnal Research

Newport Beach, California, United States

William G. Moseley

San Diego, California, United States

West Coast Clinical Research

Tarzana, California, United States

Western Clinical Research, Inc.

Torrance, California, United States

Urology Research Options

Aurora, Colorado, United States

Urologic Oncology

Aurora, Colorado, United States

Genitourinary Surgical Consultants

Denver, Colorado, United States

Connecticut Clincal Research Center

Middlebury, Connecticut, United States

South Florida Medical Research

Aventura, Florida, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

Atlantic Urological Associates

Daytona Beach, Florida, United States

Miami VACM

Miami, Florida, United States

Florida Healthcare Research

Ocala, Florida, United States

Florida Urologist Specialists

Sarasota, Florida, United States

Southeastern Research Group

Tallahassee, Florida, United States

Southwestern Medical Research Institute

Columbus, Georgia, United States

Northwestern University Feinberg School of Medecine

Chicago, Illinois, United States

Welborn Clinic

Evansville, Indiana, United States

Northeast Indiana Research, LLC

Fort Wayne, Indiana, United States

Kansas City Urology Care

Overland Park, Kansas, United States

Four Rivers Clinical Research

Paducah, Kentucky, United States

Myron I. Murdock M.D. LLC

Greenbelt, Maryland, United States

Michigan Institute of Urology

Saint Clair Shores, Michigan, United States

Washington University

St Louis, Missouri, United States

Metropolitan Urological Specialists

St Louis, Missouri, United States

Quality Clinical Research

Omaha, Nebraska, United States

Delaware Valley Urology, LLC

Woodlane, New Jersey, United States

Urology Group Of New Mexico

Albuquerque, New Mexico, United States

Medical & Clinical Research Associates

Bay Shore, New York, United States

Urological Surgeons of Long Island, Clinical Research Division

Garden City, New York, United States

New York University School of Medecine

New York, New York, United States

University Urology

New York, New York, United States

Hudson Valley Urology

Poughkeepsie, New York, United States

Northeast Urology Research

Concord, North Carolina, United States

Parkhurst Research Oganization Inc.

Bethany, Oklahoma, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Vanderbilt University medical Center

Nashville, Tennessee, United States

Corpus Christi Urology Group

Corpus Christi, Texas, United States

Urology Clinics of North Texas

Dallas, Texas, United States

University of Texas Southwestern Medical Center, Department of Urology

Dallas, Texas, United States

Institute and the Texas Prostate Center

Houston, Texas, United States

Urology San Antonio Research, PA

San Antonio, Texas, United States

Integrity Medical Research

Mountlake Terrace, Washington, United States

National Oncological Hospital

Sofia, , Bulgaria

Southern Interior Medical Research Inc.

Kelowna, British Columbia, Canada

Andreou Research Inc.

Surrey, British Columbia, Canada

Can-Med Clinical Reserach Inc.

Victoria, British Columbia, Canada

The Male / FemaleHealth and Research Center

Barrie, Ontario, Canada

Centre for Advanced Urological Research

Kingston, Ontario, Canada

Urologic Associates, Urologic Medical Research

Kitchener, Ontario, Canada

Canada Place Building

North Bay, Ontario, Canada

The Fe/Male Health Centers

Oakville, Ontario, Canada

University Health Network Princess Margaret Hospital

Toronto, Ontario, Canada

The Male Health Center

Toronto, Ontario, Canada

Urology South Shore Research

Greenfield Park, Quebec, Canada

CHUM, Hopital St-Luc

Montreal, Quebec, Canada

Dynamik Research

Pointe-Claire, Quebec, Canada

CRCEO

Québec, Quebec, Canada

ClinPharm International GmbH Prufzentrum Berlin

Berlin, , Germany

ClinPharm International GmbH Prufzentrum Bochum

Bochum, , Germany

ClinPharm International GmbH Prufzentrum Dresden

Dresden, , Germany

ClinPharm International GmbH Prufzentrum Frankfurt

Frankfurt, , Germany

ClinPharm International GmbH Prufzentrum Gorlitz

Görlitz, , Germany

ClinPharm International GmbH Prufzentrum Leipzig

Leipzig, , Germany

ClinPharm International GmbH Prufzentrum Magdeburg

Magdeburg, , Germany

Countries

United States; Bulgaria; Canada; Germany

Other Identifiers

Z033

Identifier Type: -

Identifier Source: org_study_id