Clinical trial NCT00670306: Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Official title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hypertrophy
Keywords: Cetrorelix
BPH
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 528
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: IPSS Change From Baseline
timeFrame: Baseline and Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Laguna Hills
country: United States
facility: South Orange County Medical Research Center
state: California
city: Newport Beach
country: United States
facility: California Professionnal Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: San Diego Uro Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Middlebury
country: United States
facility: Connecticut Clincal Research Center, LLC
state: Connecticut
city: Trumbull
country: United States
facility: Urological Associates of Bridgeport
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Lake Worth
country: United States
facility: University Urologists
state: Florida
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology
state: Florida
city: Sarasota
country: United States
facility: Florida Urology Specialists
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Fort Wayne
country: United States
facility: Northeast Indiana Research, LLC
state: Indiana
city: Newburgh
country: United States
facility: Welborn Clinic
state: Indiana
city: Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Bel Air
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Greenbelt
country: United States
facility: Myron I. Murdock M.D. LLC
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: St-Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Missoula
country: United States
facility: Five Valleys Urology
state: Montana
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Sheldon J. Freedman, MD, LTD
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrenceville Urology, P.A. dba AdvanceMed Research
state: New Jersey
city: Voorhees
country: United States
facility: Delaware Valley Urology, LLC-Voorhees
state: New Jersey
city: Westampton
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Albany
country: United States
facility: Upstate Urology
state: New York
city: Albany
country: United States
facility: Capital Region Urologic Surgeons
state: New York
city: Bay Shore
country: United States
facility: Medical & Clinical Research Associates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of Long Island, Clinical Research Division
state: New York
city: Jackson Heights
country: United States
facility: Advanced Urology
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New-York
country: United States
facility: University Urology Associates
state: New York
city: Rochester
country: United States
facility: Urology Associates-Rochester
state: New York
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Group
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Bethany
country: United States
facility: Parkhurst Research Oganization Inc.
state: Oklahoma
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SEPA
state: Pennsylvania
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Greer
country: United States
facility: Matrix Research
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Department of Urology
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research, PLLC
state: Utah
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Urology Research
state: Washington
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Barrie
country: Canada
facility: The Male / FemaleHealth and Research Center
state: Ontario
city: Brampton
country: Canada
facility: Dr. Jonathan Giddens
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: Guelph
country: Canada
facility: Guelph Urology Associates
state: Ontario
city: Kitchener
country: Canada
facility: Urologic Associates, Urologic Medical Research
state: Ontario
city: New Market
country: Canada
facility: Mor Urology, Inc.
state: Ontario
city: North Bay
country: Canada
facility: Dr. Bernard Goldfarb, MD
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centres
state: Ontario
city: Ottawa,
country: Canada
facility: Dr. John Mahoney
state: Ontario
city: Scarborough
country: Canada
facility: Allan Abramovitch, MD
state: Ontario
city: Thunder Bay,
country: Canada
facility: Anthony Skehan Medicine Professional Corp.
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Center
state: Ontario
Study officials:
References: