Clinical trial NCT00449150: Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Official title: Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Benign Prostatic Hypertrophy
Keywords: Cetrorelix
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 667
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Benign Prostatic Hyperplasia, based on medical history
* Voiding symptoms

Exclusion Criteria:

* 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

Primary outcomes:
measure: International Prostate Symptoms Score (IPSS)
timeFrame: Baseline and 52 weeks
Secondary outcomes:
measure: Time Course of Quality of Life
timeFrame: Quality of life assessment in the following weeks: 4,12,26,30,38,46,52
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Fort Smith
country: United States
facility: Urology Group of Westrn Arkansas
state: Arkansas
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: San Diego
country: United States
facility: William G. Moseley
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Urology Research Options
state: Colorado
city: Aurora
country: United States
facility: Urologic Oncology
state: Colorado
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Middlebury
country: United States
facility: Connecticut Clincal Research Center
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: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Miami
country: United States
facility: Miami VACM
state: Florida
city: Ocala
country: United States
facility: Florida Healthcare Research
state: Florida
city: Sarasota
country: United States
facility: Florida Urologist Specialists
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Research Group
state: Florida
city: Columbus
country: United States
facility: Southwestern Medical Research Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medecine
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Fort Wayne
country: United States
facility: Northeast Indiana Research, LLC
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Urology Care
state: Kansas
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: Greenbelt
country: United States
facility: Myron I. Murdock M.D. LLC
state: Maryland
city: Saint Clair Shores
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Metropolitan Urological Specialists
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Westampton
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group Of New Mexico
state: New Mexico
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: New York
country: United States
facility: New York University School of Medecine
state: New York
city: New York
country: United States
facility: University Urology
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology
state: New York
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Bethany
country: United States
facility: Parkhurst Research Oganization Inc.
state: Oklahoma
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University medical Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Corpus Christi Urology Group
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Department of Urology
state: Texas
city: Houston
country: United States
facility: Institute and the Texas Prostate Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research, PA
state: Texas
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
city: Sofia
country: Bulgaria
facility: National Oncological Hospital
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Andreou Research Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Reserach Inc.
state: British Columbia
city: Barrie
country: Canada
facility: The Male / FemaleHealth and Research Center
state: Ontario
city: Kingston
country: Canada
facility: Centre for Advanced Urological Research
state: Ontario
city: Kitchener
country: Canada
facility: Urologic Associates, Urologic Medical Research
state: Ontario
city: North Bay
country: Canada
facility: Canada Place Building
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centers
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Center
state: Ontario
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
city: Montréal
country: Canada
facility: CHUM, Hopital St-Luc
state: Quebec
city: Pointe Claire
country: Canada
facility: Dynamik Research
state: Quebec
city: Québec
country: Canada
facility: CRCEO
state: Quebec
city: Berlin
country: Germany
facility: ClinPharm International GmbH Prufzentrum Berlin
city: Bochum
country: Germany
facility: ClinPharm International GmbH Prufzentrum Bochum
city: Dresden
country: Germany
facility: ClinPharm International GmbH Prufzentrum Dresden
city: Frankfurt
country: Germany
facility: ClinPharm International GmbH Prufzentrum Frankfurt
city: Gorlitz
country: Germany
facility: ClinPharm International GmbH Prufzentrum Gorlitz
city: Leipzig
country: Germany
facility: ClinPharm International GmbH Prufzentrum Leipzig
city: Magdeburg
country: Germany
facility: ClinPharm International GmbH Prufzentrum Magdeburg
Study officials:
affiliation: NYU Langone Health
name: Dr. Hebert Lepor, MD
role: PRINCIPAL_INVESTIGATOR
References: