Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hypertrophy Clinical Trial

— AEZS-102-Z041  

Official title:

Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670306
• Other study ID #: AEZS-102-Z041
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2008
• Last updated: April 1, 2011
• Start date: March 2008
• Est. completion date: August 2009

Study information

• Verified date: April 2011
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with a 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Drug:
• Cetrorelix Pamoate
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No