Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) (AEZS-102-Z041)

April 1, 2011 updated by: AEterna Zentaris

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

528

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetrorelix 78 mg
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
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
Other Names:
  • Cetrorelix pamoate, D-20762, AEZS-102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPSS Change From Baseline
Time Frame: Baseline and Week 26
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AEterna Zentaris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 5, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEZS-102-Z041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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