Back to resultsCetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Primary Purpose
Benign Prostatic Hypertrophy
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cetrorelix 78 mg + 78 mg
Cetrorelix 78 mg + 52 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hypertrophy focused on measuring Cetrorelix
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
Sites / Locations
- Medical Affiliated Research Center, Inc.
- Urology Group of Westrn Arkansas
- South Orange County Medical Research Center
- California Professionnal Research
- William G. Moseley
- West Coast Clinical Research
- Western Clinical Research, Inc.
- Urology Research Options
- Urologic Oncology
- Genitourinary Surgical Consultants
- Connecticut Clincal Research Center
- South Florida Medical Research
- Tampa Bay Medical Research
- Atlantic Urological Associates
- Miami VACM
- Florida Healthcare Research
- Florida Urologist Specialists
- Southeastern Research Group
- Southwestern Medical Research Institute
- Northwestern University Feinberg School of Medecine
- Welborn Clinic
- Northeast Indiana Research, LLC
- Kansas City Urology Care
- Four Rivers Clinical Research
- Myron I. Murdock M.D. LLC
- Michigan Institute of Urology
- Washington University
- Metropolitan Urological Specialists
- Quality Clinical Research
- Delaware Valley Urology, LLC
- Urology Group Of New Mexico
- Medical & Clinical Research Associates
- Urological Surgeons of Long Island, Clinical Research Division
- New York University School of Medecine
- University Urology
- Hudson Valley Urology
- Northeast Urology Research
- Parkhurst Research Oganization Inc.
- Carolina Urologic Research Center
- Vanderbilt University medical Center
- Corpus Christi Urology Group
- Urology Clinics of North Texas
- University of Texas Southwestern Medical Center, Department of Urology
- Institute and the Texas Prostate Center
- Urology San Antonio Research, PA
- Integrity Medical Research
- National Oncological Hospital
- Southern Interior Medical Research Inc.
- Andreou Research Inc.
- Can-Med Clinical Reserach Inc.
- The Male / FemaleHealth and Research Center
- Centre for Advanced Urological Research
- Urologic Associates, Urologic Medical Research
- Canada Place Building
- The Fe/Male Health Centers
- University Health Network Princess Margaret Hospital
- The Male Health Center
- Urology South Shore Research
- CHUM, Hopital St-Luc
- Dynamik Research
- CRCEO
- ClinPharm International GmbH Prufzentrum Berlin
- ClinPharm International GmbH Prufzentrum Bochum
- ClinPharm International GmbH Prufzentrum Dresden
- ClinPharm International GmbH Prufzentrum Frankfurt
- ClinPharm International GmbH Prufzentrum Gorlitz
- ClinPharm International GmbH Prufzentrum Leipzig
- ClinPharm International GmbH Prufzentrum Magdeburg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment Group A: CET 78 mg + 78 mg
Treatment Group B: CET 78 mg + 52 mg
Treatment Group C: Placebo
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
International Prostate Symptoms Score (IPSS)
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)
Secondary Outcome Measures
Time Course of Quality of Life
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00449150
Brief Title
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
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Trial did not meet primary efficacy endpoint for double blind phase.
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEterna Zentaris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy
Keywords
Cetrorelix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
667 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group A: CET 78 mg + 78 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Group B: CET 78 mg + 52 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Group C: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetrorelix 78 mg + 78 mg
Other Intervention Name(s)
CET, AEZS-102
Intervention Type
Drug
Intervention Name(s)
Cetrorelix 78 mg + 52 mg
Other Intervention Name(s)
CET, AEZS-102
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (PLA)
Primary Outcome Measure Information:
Title
International Prostate Symptoms Score (IPSS)
Description
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)
Time Frame
Baseline and 52 weeks
Secondary Outcome Measure Information:
Title
Time Course of Quality of Life
Description
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.
Time Frame
Quality of life assessment in the following weeks: 4,12,26,30,38,46,52
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Hebert Lepor, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Urology Group of Westrn Arkansas
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
California Professionnal Research
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
William G. Moseley
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
West Coast Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Western Clinical Research, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Urology Research Options
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Urologic Oncology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-0510
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Connecticut Clincal Research Center
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Miami VACM
City
Miami
State/Province
Florida
ZIP/Postal Code
33125-1693
Country
United States
Facility Name
Florida Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Urologist Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Southeastern Research Group
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Southwestern Medical Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Northwestern University Feinberg School of Medecine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Kansas City Urology Care
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Myron I. Murdock M.D. LLC
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Michigan Institute of Urology
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Metropolitan Urological Specialists
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Delaware Valley Urology, LLC
City
Westampton
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Urology Group Of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Medical & Clinical Research Associates
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Urological Surgeons of Long Island, Clinical Research Division
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
New York University School of Medecine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University Urology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Hudson Valley Urology
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Northeast Urology Research
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Parkhurst Research Oganization Inc.
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Vanderbilt University medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Corpus Christi Urology Group
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Southwestern Medical Center, Department of Urology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9110
Country
United States
Facility Name
Institute and the Texas Prostate Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Integrity Medical Research
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
National Oncological Hospital
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Southern Interior Medical Research Inc.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Andreou Research Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
Facility Name
Can-Med Clinical Reserach Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
The Male / FemaleHealth and Research Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Centre for Advanced Urological Research
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Urologic Associates, Urologic Medical Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N4
Country
Canada
Facility Name
Canada Place Building
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 7K8
Country
Canada
Facility Name
The Fe/Male Health Centers
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
University Health Network Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
The Male Health Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
CHUM, Hopital St-Luc
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Dynamik Research
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
CRCEO
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
ClinPharm International GmbH Prufzentrum Berlin
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
ClinPharm International GmbH Prufzentrum Bochum
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
ClinPharm International GmbH Prufzentrum Dresden
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
ClinPharm International GmbH Prufzentrum Frankfurt
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
ClinPharm International GmbH Prufzentrum Gorlitz
City
Gorlitz
ZIP/Postal Code
02826
Country
Germany
Facility Name
ClinPharm International GmbH Prufzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
ClinPharm International GmbH Prufzentrum Magdeburg
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
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