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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
528

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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