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

Primary Purpose

Benign Prostatic Hypertrophy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cetrorelix Pamoate
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy focused on measuring Cetrorelix, BPH

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Centers of Alabama
  • Medical Affiliated Research Center, Inc.
  • South Orange County Medical Research Center
  • California Professionnal Research
  • Northern California Research
  • San Diego Uro Research
  • Medical Center for Clinical Research
  • West Coast Clinical Research
  • Genitourinary Surgical Consultants
  • Connecticut Clincal Research Center, LLC
  • Urological Associates of Bridgeport
  • South Florida Medical Research
  • Tampa Bay Medical Research
  • University Urologists
  • Specialists in Urology
  • Winter Park Urology
  • Florida Urology Specialists
  • Mount Vernon Clinical Research, LLC
  • North Idaho Urology
  • Northeast Indiana Research, LLC
  • Welborn Clinic
  • The Iowa Clinic
  • Four Rivers Clinical Research
  • Regional Urology, LLC
  • Chesapeake Urology Research Associates
  • Myron I. Murdock M.D. LLC
  • Michigan Institute of Urology
  • Washington University School of Medicine
  • Five Valleys Urology
  • Quality Clinical Research, Inc.
  • Meridian Clinical Research LLC
  • Sheldon J. Freedman, MD, LTD
  • Lawrenceville Urology, P.A. dba AdvanceMed Research
  • Delaware Valley Urology, LLC-Voorhees
  • Delaware Valley Urology, LLC
  • Upstate Urology
  • Capital Region Urologic Surgeons
  • Medical & Clinical Research Associates
  • Urological Surgeons of Long Island, Clinical Research Division
  • Advanced Urology
  • New York University School of Medicine
  • University Urology Associates
  • Urology Associates-Rochester
  • Northeast Urology Research
  • Piedmont Medical Group
  • The Urology Group
  • Parkhurst Research Oganization Inc.
  • Urologic Consultants of SEPA
  • Urological Associates of Lancaster
  • Omega Medical Research
  • Matrix Research
  • Carolina Urologic Research Center
  • University of Texas Southwestern Medical Center, Department of Urology
  • Salt Lake Research, PLLC
  • Urology of Virginia
  • Seattle Urology Research
  • Can-Med Clinical Research Inc.
  • The Male / FemaleHealth and Research Center
  • Dr. Jonathan Giddens
  • Brantford Urology Research
  • Guelph Urology Associates
  • Urologic Associates, Urologic Medical Research
  • Mor Urology, Inc.
  • Dr. Bernard Goldfarb, MD
  • The Fe/Male Health Centres
  • Dr. John Mahoney
  • Allan Abramovitch, MD
  • Anthony Skehan Medicine Professional Corp.
  • The Male Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetrorelix 78 mg

Arm Description

Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 22, 2008
Last Updated
April 1, 2011
Sponsor
AEterna Zentaris
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1. Study Identification

Unique Protocol Identification Number
NCT00670306
Brief Title
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Acronym
AEZS-102-Z041
Official Title
Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AEterna Zentaris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy
Keywords
Cetrorelix, BPH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
528 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetrorelix 78 mg
Arm Type
Experimental
Arm Description
Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Intervention Type
Drug
Intervention Name(s)
Cetrorelix Pamoate
Other Intervention Name(s)
Cetrorelix pamoate, D-20762, AEZS-102
Intervention Description
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
Primary Outcome Measure Information:
Title
IPSS Change From Baseline
Description
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
Time Frame
Baseline and Week 26

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

12. IPD Sharing Statement

Learn more about this trial

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

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