Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) - Full Text View

Sponsor:	AEterna Zentaris
Information provided by:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT00670306

Purpose

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).

Condition	Intervention	Phase
Benign Prostatic Hyperplasia (BPH)	Drug: Cetrorelix Pamoate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Cetrorelix Pamoate (AEZS-102)in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study

Resource links provided by NLM:

Drug Information available for: Cetrorelix Cetrorelix acetate

U.S. FDA Resources

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:

Incidence of treatment-emergent AEs [ Time Frame: Patient receiving at least one dose of medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

BPH Symptoms [ Time Frame: Patient questionnaire ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	March 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.	Drug: Cetrorelix Pamoate 52 mg week 0, 26 mg week 2,

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Benign Prostatic Hyperplasia, based on medical history
Voiding symptoms
Uroflow (max) 5-15mL/sec

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670306

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Locations

United States, Alabama
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
United States, California
California Professionnal Research
Newport Beach, California, United States, 92660
South Orange County Medical Research Center
Laguna Hills, California, United States, 92653
Northern California Research
Sacramento, California, United States, 95831
San Diego Uro Research
San Diego, California, United States, 92103
Medical Center for Clinical Research
San Diego, California, United States, 92108
West Coast Clinical Research
Tarzana, California, United States, 91356
United States, Colorado
Genitourinary Surgical Consultants
Denver, Colorado, United States, 80220
United States, Connecticut
Connecticut Clincal Research Center, LLC
Middlebury, Connecticut, United States, 06762
Urological Associates of Bridgeport
Trumbull, Connecticut, United States, 06611
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
University Urologists
Lake Worth, Florida, United States, 33461
Winter Park Urology
Orlando, Florida, United States, 32803
Specialists in Urology
Naples, Florida, United States, 34102
Florida Urology Specialists
Sarasota, Florida, United States, 34237
United States, Georgia
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States, 30328
United States, Idaho
North Idaho Urology
Coeur d'Alene, Idaho, United States, 50309
United States, Indiana
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States, 46825
Welborn Clinic
Newburgh, Indiana, United States, 47630
United States, Iowa
The Iowa Clinic
Des Moines, Iowa, United States, 50309
United States, Kentucky
Four Rivers Clinical Research
Paducah, Kentucky, United States, 42003
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Maryland
Myron I. Murdock M.D. LLC
Greenbelt, Maryland, United States, 20770
Chesapeake Urology Research Associates
Bel Air, Maryland, United States, 21014
United States, Michigan
Michigan Institute of Urology
Troy, Michigan, United States, 48084
United States, Missouri
Washington University School of Medicine
St-Louis, Missouri, United States, 63110
United States, Montana
Five Valleys Urology
Missoula, Montana, United States, 59802
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
Meridian Clinical Research LLC
Omaha, Nebraska, United States, 68134
United States, Nevada
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Delaware Valley Urology, LLC
Westampton, New Jersey, United States, 08060
Lawrenceville Urology, P.A. dba AdvanceMed Research
Lawrenceville, New Jersey, United States, 08648
Delaware Valley Urology, LLC-Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Medical & Clinical Research Associates
Bay Shore, New York, United States, 11706
New York University School of Medicine
New York, New York, United States, 10016
University Urology Associates
New-York, New York, United States, 10016
Urological Surgeons of Long Island, Clinical Research Division
Garden City, New York, United States, 11530
Capital Region Urologic Surgeons
Albany, New York, United States, 12208
Advanced Urology
Jackson Heights, New York, United States, 11372
Upstate Urology
Albany, New York, United States, 12206
Urology Associates-Rochester
Rochester, New York, United States, 14618
United States, North Carolina
Northeast Urology Research
Concord, North Carolina, United States, 28025
Piedmont Medical Group
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
The Urology Group
Cincinnati, Ohio, United States, 45212
United States, Oklahoma
Parkhurst Research Oganization Inc.
Bethany, Oklahoma, United States, 73008
United States, Pennsylvania
Urologic Consultants of SEPA
Bala Cynwyd, Pennsylvania, United States, 19004
Urological Associates of Lancaster
Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Matrix Research
Greer, South Carolina, United States, 29650
United States, Texas
University of Texas Southwestern Medical Center, Department of Urology
Dallas, Texas, United States, 75390-9110
United States, Utah
Salt Lake Research, PLLC
Salt Lake City, Utah, United States, 84107
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23454
United States, Washington
Seattle Urology Research
Seattle, Washington, United States, 98166
Canada, British Columbia
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada, V8T 5G1
Canada, Ontario
The Fe/Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
The Male Health Center
Toronto, Ontario, Canada, M6A 3B5
Urologic Associates, Urologic Medical Research
Kitchener, Ontario, Canada, N2M 5N4
Dr. Bernard Goldfarb, MD
North Bay, Ontario, Canada, P1B 7K8
Anthony Skehan Medicine Professional Corp.
Thunder Bay,, Ontario, Canada, P7E 6E7
Allan Abramovitch, MD
Scarborough, Ontario, Canada, M1S4V5
Dr. Jonathan Giddens
Brampton, Ontario, Canada, L6T 4S5
Guelph Urology Associates
Guelph, Ontario, Canada, N1H5J1
Brantford Urology Research
Brantford, Ontario, Canada, N3R 4N3
Mor Urology, Inc.
New Market, Ontario, Canada, L3X 1W1
Dr. John Mahoney
Ottawa,, Ontario, Canada, K1H 8L6
The Male / FemaleHealth and Research Center
Barrie, Ontario, Canada, L4M 7G1

Sponsors and Collaborators

AEterna Zentaris

More Information

No publications provided

Responsible Party:	AEterna Zentaris ( Daniel Croteau / Medical Manager )
Study ID Numbers:	AEZS-102-Z041
Study First Received:	April 22, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00670306 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:

Cetrorelix
BPH

Additional relevant MeSH terms:

Hyperplasia
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cetrorelix
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009