Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
AEZS-102-Z041
Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study
1 other identifier
interventional
528
2 countries
69
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2008
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
January 19, 2011
CompletedApril 5, 2011
April 1, 2011
1.4 years
April 22, 2008
October 18, 2010
April 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IPSS Change From Baseline
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
Baseline and Week 26
Study Arms (1)
Cetrorelix 78 mg
EXPERIMENTALDrug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Interventions
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
Eligibility Criteria
You may qualify if:
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
- Uroflow (max) 5-15mL/sec
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AEterna Zentarislead
Study Sites (69)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
South Orange County Medical Research Center
Laguna Hills, California, 92653, United States
California Professionnal Research
Newport Beach, California, 92660, United States
Northern California Research
Sacramento, California, 95831, United States
San Diego Uro Research
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
West Coast Clinical Research
Tarzana, California, 91356, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Connecticut Clincal Research Center, LLC
Middlebury, Connecticut, 06762, United States
Urological Associates of Bridgeport
Trumbull, Connecticut, 06611, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
University Urologists
Lake Worth, Florida, 33461, United States
Specialists in Urology
Naples, Florida, 34102, United States
Winter Park Urology
Orlando, Florida, 32803, United States
Florida Urology Specialists
Sarasota, Florida, 34237, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
North Idaho Urology
Coeur d'Alene, Idaho, 50309, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825, United States
Welborn Clinic
Newburgh, Indiana, 47630, United States
The Iowa Clinic
Des Moines, Iowa, 50309, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Bel Air, Maryland, 21014, United States
Myron I. Murdock M.D. LLC
Greenbelt, Maryland, 20770, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Five Valleys Urology
Missoula, Montana, 59802, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Meridian Clinical Research LLC
Omaha, Nebraska, 68134, United States
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, 89148, United States
Lawrenceville Urology, P.A. dba AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Delaware Valley Urology, LLC-Voorhees
Voorhees Township, New Jersey, 08043, United States
Delaware Valley Urology, LLC
Woodlane, New Jersey, 08060, United States
Upstate Urology
Albany, New York, 12206, United States
Capital Region Urologic Surgeons
Albany, New York, 12208, United States
Medical & Clinical Research Associates
Bay Shore, New York, 11706, United States
Urological Surgeons of Long Island, Clinical Research Division
Garden City, New York, 11530, United States
Advanced Urology
Jackson Heights, New York, 11372, United States
New York University School of Medicine
New York, New York, 10016, United States
University Urology Associates
New York, New York, 10016, United States
Urology Associates-Rochester
Rochester, New York, 14618, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
Piedmont Medical Group
Winston-Salem, North Carolina, 27103, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Parkhurst Research Oganization Inc.
Bethany, Oklahoma, 73008, United States
Urologic Consultants of SEPA
Bala-Cynwyd, Pennsylvania, 19004, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Matrix Research
Greer, South Carolina, 29650, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
University of Texas Southwestern Medical Center, Department of Urology
Dallas, Texas, 75390-9110, United States
Salt Lake Research, PLLC
Salt Lake City, Utah, 84107, United States
Urology of Virginia
Virginia Beach, Virginia, 23454, United States
Seattle Urology Research
Seattle, Washington, 98166, United States
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T 5G1, Canada
The Male / FemaleHealth and Research Center
Barrie, Ontario, L4M 7G1, Canada
Dr. Jonathan Giddens
Brampton, Ontario, L6T 4S5, Canada
Brantford Urology Research
Brantford, Ontario, N3R 4N3, Canada
Guelph Urology Associates
Guelph, Ontario, N1H5J1, Canada
Urologic Associates, Urologic Medical Research
Kitchener, Ontario, N2M 5N4, Canada
Mor Urology, Inc.
Newmarket, Ontario, L3X 1W1, Canada
Dr. Bernard Goldfarb, MD
North Bay, Ontario, P1B 7K8, Canada
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Dr. John Mahoney
Ottawa, Ontario, K1H 8L6, Canada
Allan Abramovitch, MD
Scarborough Village, Ontario, M1S4V5, Canada
Anthony Skehan Medicine Professional Corp.
Thunder Bay, Ontario, P7E 6E7, Canada
The Male Health Center
Toronto, Ontario, M6A 3B5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Croteau, Medical Manager
- Organization
- AEterna Zentaris
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 22, 2008
First Posted
May 1, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
April 5, 2011
Results First Posted
January 19, 2011
Record last verified: 2011-04