Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
- Registration Number
- NCT00670306
- Lead Sponsor
- AEterna Zentaris
- Brief Summary
Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate.
For this study, study medication (Cetrorelix pamoate) is administered by injection in the buttocks (Intramuscular).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 528
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
- Uroflow (max) 5-15mL/sec
- Urgent need for prostate surgery
- History of allergic reaction to peptide
- Major organ dysfunction
- Prior surgical treatment of the prostate or bladder
- 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 to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cetrorelix 78 mg Cetrorelix Pamoate Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
- Primary Outcome Measures
Name Time Method IPSS Change From Baseline Baseline and Week 26 International Prostate Symptom Score (IPSS) 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 - 35 points; absolute change from baseline to Week 26
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (69)
Dr. Jonathan Giddens
🇨🇦Brampton, Ontario, Canada
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Five Valleys Urology
🇺🇸Missoula, Montana, United States
Delaware Valley Urology, LLC-Voorhees
🇺🇸Voorhees, New Jersey, United States
Can-Med Clinical Research Inc.
🇨🇦Victoria, British Columbia, Canada
South Orange County Medical Research Center
🇺🇸Laguna Hills, California, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Upstate Urology
🇺🇸Albany, New York, United States
Advanced Urology
🇺🇸Jackson Heights, New York, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
University Urology Associates
🇺🇸New-York, New York, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Specialists in Urology
🇺🇸Naples, Florida, United States
Welborn Clinic
🇺🇸Newburgh, Indiana, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
Urologic Consultants of SEPA
🇺🇸Bala Cynwyd, Pennsylvania, 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
California Professionnal Research
🇺🇸Newport Beach, California, United States
Florida Urology Specialists
🇺🇸Sarasota, Florida, United States
Winter Park Urology
🇺🇸Orlando, Florida, United States
The Iowa Clinic
🇺🇸Des Moines, Iowa, United States
Urological Associates of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Delaware Valley Urology, LLC
🇺🇸Westampton, New Jersey, United States
The Male / FemaleHealth and Research Center
🇨🇦Barrie, Ontario, Canada
Brantford Urology Research
🇨🇦Brantford, Ontario, Canada
Mor Urology, Inc.
🇨🇦New Market, Ontario, Canada
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Lawrenceville Urology, P.A. dba AdvanceMed Research
🇺🇸Lawrenceville, New Jersey, United States
Medical & Clinical Research Associates
🇺🇸Bay Shore, New York, United States
The Fe/Male Health Centres
🇨🇦Oakville, Ontario, Canada
Washington University School of Medicine
🇺🇸St-Louis, Missouri, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Capital Region Urologic Surgeons
🇺🇸Albany, New York, United States
Urology Associates-Rochester
🇺🇸Rochester, New York, United States
Parkhurst Research Oganization Inc.
🇺🇸Bethany, Oklahoma, United States
Urologic Associates, Urologic Medical Research
🇨🇦Kitchener, Ontario, Canada
Dr. Bernard Goldfarb, MD
🇨🇦North Bay, Ontario, Canada
Seattle Urology Research
🇺🇸Seattle, Washington, United States
San Diego Uro Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Salt Lake Research, PLLC
🇺🇸Salt Lake City, Utah, United States
Genitourinary Surgical Consultants
🇺🇸Denver, Colorado, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Sheldon J. Freedman, MD, LTD
🇺🇸Las Vegas, Nevada, United States
Dr. John Mahoney
🇨🇦Ottawa,, Ontario, Canada
Allan Abramovitch, MD
🇨🇦Scarborough, Ontario, Canada
The Male Health Center
🇨🇦Toronto, Ontario, Canada
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Meridian Clinical Research LLC
🇺🇸Omaha, Nebraska, United States
West Coast Clinical Research
🇺🇸Tarzana, California, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Urological Associates of Bridgeport
🇺🇸Trumbull, Connecticut, United States
Northern California Research
🇺🇸Sacramento, California, United States
Connecticut Clincal Research Center, LLC
🇺🇸Middlebury, Connecticut, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Chesapeake Urology Research Associates
🇺🇸Bel Air, Maryland, United States
University Urologists
🇺🇸Lake Worth, Florida, United States
Urological Surgeons of Long Island, Clinical Research Division
🇺🇸Garden City, New York, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Piedmont Medical Group
🇺🇸Winston-Salem, North Carolina, United States
Guelph Urology Associates
🇨🇦Guelph, Ontario, Canada
Anthony Skehan Medicine Professional Corp.
🇨🇦Thunder Bay,, Ontario, Canada
University of Texas Southwestern Medical Center, Department of Urology
🇺🇸Dallas, Texas, United States
Matrix Research
🇺🇸Greer, South Carolina, United States