Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
- Conditions
- Benign Prostatic Hypertrophy
- Interventions
- Registration Number
- NCT00449150
- Lead Sponsor
- AEterna Zentaris
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 667
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group B: CET 78 mg + 52 mg Placebo 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. Treatment Group C: Placebo 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. Treatment Group A: CET 78 mg + 78 mg Cetrorelix 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. Treatment Group B: CET 78 mg + 52 mg Cetrorelix 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.
- Primary Outcome Measures
Name Time Method International Prostate Symptoms Score (IPSS) Baseline and 52 weeks 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)
- Secondary Outcome Measures
Name Time Method Time Course of Quality of Life Quality of life assessment in the following weeks: 4,12,26,30,38,46,52 The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.
Trial Locations
- Locations (68)
Kansas City Urology Care
🇺🇸Overland Park, Kansas, United States
Corpus Christi Urology Group
🇺🇸Corpus Christi, Texas, United States
Centre for Advanced Urological Research
🇨🇦Kingston, Ontario, Canada
William G. Moseley
🇺🇸San Diego, California, United States
Institute and the Texas Prostate Center
🇺🇸Houston, Texas, United States
Genitourinary Surgical Consultants
🇺🇸Denver, Colorado, United States
Vanderbilt University medical Center
🇺🇸Nashville, Tennessee, United States
The Fe/Male Health Centers
🇨🇦Oakville, Ontario, Canada
ClinPharm International GmbH Prufzentrum Magdeburg
🇩🇪Magdeburg, Germany
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Urology Group of Westrn Arkansas
🇺🇸Fort Smith, Arkansas, United States
California Professionnal Research
🇺🇸Newport Beach, California, United States
South Orange County Medical Research Center
🇺🇸Laguna Hills, California, United States
Western Clinical Research, Inc.
🇺🇸Torrance, California, United States
West Coast Clinical Research
🇺🇸Tarzana, California, United States
Urology Research Options
🇺🇸Aurora, Colorado, United States
Urologic Oncology
🇺🇸Aurora, Colorado, United States
Miami VACM
🇺🇸Miami, Florida, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Florida Healthcare Research
🇺🇸Ocala, Florida, United States
Southeastern Research Group
🇺🇸Tallahassee, Florida, United States
Florida Urologist Specialists
🇺🇸Sarasota, Florida, 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
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
Myron I. Murdock M.D. LLC
🇺🇸Greenbelt, Maryland, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Metropolitan Urological Specialists
🇺🇸Saint Louis, Missouri, United States
Delaware Valley Urology, LLC
🇺🇸Westampton, New Jersey, United States
Urology Group Of New Mexico
🇺🇸Albuquerque, New Mexico, United States
New York University School of Medecine
🇺🇸New York, New York, 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
Hudson Valley Urology
🇺🇸Poughkeepsie, New York, United States
University Urology
🇺🇸New York, New York, United States
Parkhurst Research Oganization Inc.
🇺🇸Bethany, Oklahoma, United States
University of Texas Southwestern Medical Center, Department of Urology
🇺🇸Dallas, Texas, United States
Urology San Antonio Research, PA
🇺🇸San Antonio, Texas, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Southern Interior Medical Research Inc.
🇨🇦Kelowna, British Columbia, Canada
National Oncological Hospital
🇧🇬Sofia, Bulgaria
Integrity Medical Research
🇺🇸Mountlake Terrace, Washington, United States
Andreou Research Inc.
🇨🇦Surrey, British Columbia, Canada
Urologic Associates, Urologic Medical Research
🇨🇦Kitchener, Ontario, Canada
Can-Med Clinical Reserach Inc.
🇨🇦Victoria, British Columbia, Canada
The Male / FemaleHealth and Research Center
🇨🇦Barrie, Ontario, Canada
Canada Place Building
🇨🇦North Bay, Ontario, Canada
CHUM, Hopital St-Luc
🇨🇦Montréal, Quebec, Canada
University Health Network Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Urology South Shore Research
🇨🇦Greenfield Park, Quebec, Canada
Dynamik Research
🇨🇦Pointe Claire, Quebec, Canada
CRCEO
🇨🇦Québec, Quebec, Canada
ClinPharm International GmbH Prufzentrum Bochum
🇩🇪Bochum, Germany
ClinPharm International GmbH Prufzentrum Berlin
🇩🇪Berlin, Germany
ClinPharm International GmbH Prufzentrum Dresden
🇩🇪Dresden, Germany
ClinPharm International GmbH Prufzentrum Leipzig
🇩🇪Leipzig, Germany
ClinPharm International GmbH Prufzentrum Frankfurt
🇩🇪Frankfurt, Germany
ClinPharm International GmbH Prufzentrum Gorlitz
🇩🇪Gorlitz, Germany
Atlantic Urological Associates
🇺🇸Daytona Beach, Florida, United States
Connecticut Clincal Research Center
🇺🇸Middlebury, Connecticut, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Southwestern Medical Research Institute
🇺🇸Columbus, Georgia, United States
The Male Health Center
🇨🇦Toronto, Ontario, Canada
Michigan Institute of Urology
🇺🇸Saint Clair Shores, Michigan, United States