Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

August 1, 2018 updated by: AEterna Zentaris

Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

667

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

  • Bulgaria
      • Sofia, Bulgaria, 1756
        • National Oncological Hospital
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Southern Interior Medical Research Inc.
      • Surrey, British Columbia, Canada, V3V 1N1
        • Andreou Research Inc.
      • Victoria, British Columbia, Canada, V8T 5G1
        • Can-Med Clinical Reserach Inc.
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • The Male / FemaleHealth and Research Center
      • Kingston, Ontario, Canada, K7L 3J7
        • Centre for Advanced Urological Research
      • Kitchener, Ontario, Canada, N2M 5N4
        • Urologic Associates, Urologic Medical Research
      • North Bay, Ontario, Canada, P1B 7K8
        • Canada Place Building
      • Oakville, Ontario, Canada, L6H 3P1
        • The Fe/Male Health Centers
      • Toronto, Ontario, Canada, M6A 3B5
        • The Male Health Center
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network Princess Margaret Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Urology South Shore Research
      • Montréal, Quebec, Canada, H2X 3J4
        • CHUM, Hopital St-Luc
      • Pointe Claire, Quebec, Canada, H9R 3J1
        • Dynamik Research
      • Québec, Quebec, Canada, G1R 2J6
        • CRCEO
  • Germany
      • Berlin, Germany, 12627
        • ClinPharm International GmbH Prufzentrum Berlin
      • Bochum, Germany, 44787
        • ClinPharm International GmbH Prufzentrum Bochum
      • Dresden, Germany, 01067
        • ClinPharm International GmbH Prufzentrum Dresden
      • Frankfurt, Germany, 60596
        • ClinPharm International GmbH Prufzentrum Frankfurt
      • Gorlitz, Germany, 02826
        • ClinPharm International GmbH Prufzentrum Gorlitz
      • Leipzig, Germany, 04103
        • ClinPharm International GmbH Prufzentrum Leipzig
      • Magdeburg, Germany, 39104
        • ClinPharm International GmbH Prufzentrum Magdeburg
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Urology Group of Westrn Arkansas
    • California
      • Laguna Hills, California, United States, 92653
        • South Orange County Medical Research Center
      • Newport Beach, California, United States, 92660
        • California Professionnal Research
      • San Diego, California, United States, 92103
        • William G. Moseley
      • Tarzana, California, United States, 91356
        • West Coast Clinical Research
      • Torrance, California, United States, 90505
        • Western Clinical Research, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Urology Research Options
      • Aurora, Colorado, United States, 80045-0510
        • Urologic Oncology
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Connecticut Clincal Research Center
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Miami, Florida, United States, 33125-1693
        • Miami VACM
      • Ocala, Florida, United States, 34474
        • Florida Healthcare Research
      • Sarasota, Florida, United States, 34237
        • Florida Urologist Specialists
      • Tallahassee, Florida, United States, 32308
        • Southeastern Research Group
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Southwestern Medical Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medecine
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
      • Fort Wayne, Indiana, United States, 46825
        • Northeast Indiana Research, LLC
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Urology Care
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Myron I. Murdock M.D. LLC
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Michigan Institute of Urology
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63136
        • Metropolitan Urological Specialists
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research
    • New Jersey
      • Westampton, New Jersey, United States, 08060
        • Delaware Valley Urology, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Urology Group of New Mexico
    • New York
      • 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
      • New York, New York, United States, 10016
        • University Urology
      • New York, New York, United States, 10016
        • New York University School of Medecine
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Northeast Urology Research
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Parkhurst Research Oganization Inc.
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Corpus Christi Urology Group
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas
      • Dallas, Texas, United States, 75390-9110
        • University of Texas Southwestern Medical Center, Department of Urology
      • Houston, Texas, United States, 77030
        • Institute and the Texas Prostate Center
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research, PA
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical 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

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group A: CET 78 mg + 78 mg

Treatment course 1: Cetrorelix 78 mg + 78 mg

  • Week 0: 52 mg CET (2 injections)
  • Week 2: 26 mg CET (1 injection)

Treatment course 2:

  • Week 26: 52 mg CET (2 injections)

  • Week 28: 26 mg CET(1 injection)

    4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Drug: Cetrorelix 78 mg + 78 mg
Other Names:
  • CET
  • AEZS-102
Experimental: Treatment Group B: CET 78 mg + 52 mg

Treatment course 1: Cetrorelix 78 mg + 52 mg

  • Week 0: 52 mg CET (2 injections)
  • Week 2: 26 mg CET (1 injection)

Treatment course 2:

  • Week 26: 52 mg CET (2 injections)

  • Week 28: Placebo (1 injection)

    4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Drug: Placebo
Other Names:
  • Placebo (PLA)
Drug: Cetrorelix 78 mg + 52 mg
Other Names:
  • CET
  • AEZS-102
Placebo Comparator: Treatment Group C: Placebo

Treatment course 1:

  • Week 0: placebo (2 injections)
  • Week 2: placebo (1 injection)

Treatment course 2:

  • Week 26: placebo (2 injections)

  • Week 28: placebo (1 injection)

    4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Drug: Placebo
Other Names:
  • Placebo (PLA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptoms Score (IPSS)
Time Frame: Baseline and 52 weeks
The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a 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 points (best) to 35 points (worst)
Baseline and 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Course of Quality of Life
Time Frame: Quality of life assessment in the following weeks: 4,12,26,30,38,46,52
The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.
Quality of life assessment in the following weeks: 4,12,26,30,38,46,52

Collaborators and Investigators

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

Sponsor

AEterna Zentaris

Investigators

  • Principal Investigator: Dr. Hebert Lepor, MD, NYU Langone Health

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, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z033

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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