Benign Prostatic HypertrophyPhase 3AEZS-102-Z041NCT00670306
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
A Phase 3 study testing Cetrorelix Pamoate in people with Benign Prostatic Hypertrophy, run by AEterna Zentaris at 69 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- Cetrorelix Pamoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 69 sitesin 2 countries
- Study dates
- Mar 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
- Uroflow (max) 5-15mL/sec
Who cannot join
- 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
Trial locations and contacts
69 sites in 2 countries.
69 sites in 2 countries
United States56 sites
Upstate Urology
Albany, New York, 12206
Capital Region Urologic Surgeons
Albany, New York, 12208
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of SEPA
Bala-Cynwyd, Pennsylvania, 19004
Medical & Clinical Research Associates
Bay Shore, New York, 11706
Chesapeake Urology Research Associates
Bel Air, Maryland, 21014
Parkhurst Research Oganization Inc.
Bethany, Oklahoma, 73008
The Urology Group
Cincinnati, Ohio, 45212
Tampa Bay Medical Research
Clearwater, Florida, 33761
North Idaho Urology
Coeur d'Alene, Idaho, 50309
Northeast Urology Research
Concord, North Carolina, 28025
University of Texas Southwestern Medical Center, Department of Urology
Dallas, Texas, 75390-9110
Genitourinary Surgical Consultants
Denver, Colorado, 80220
The Iowa Clinic
Des Moines, Iowa, 50309
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825
Urological Surgeons of Long Island, Clinical Research Division
Garden City, New York, 11530
Myron I. Murdock M.D. LLC
Greenbelt, Maryland, 20770
Matrix Research
Greer, South Carolina, 29650
Urology Centers of Alabama
Homewood, Alabama, 35209
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
Advanced Urology
Jackson Heights, New York, 11372
South Orange County Medical Research Center
Laguna Hills, California, 92653
University Urologists
Lake Worth, Florida, 33461
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, 89148
Lawrenceville Urology, P.A. dba AdvanceMed Research
Lawrenceville, New Jersey, 08648
Connecticut Clincal Research Center, LLC
Middlebury, Connecticut, 06762
Five Valleys Urology
Missoula, Montana, 59802
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Specialists in Urology
Naples, Florida, 34102
New York University School of Medicine
New York, New York, 10016
University Urology Associates
New York, New York, 10016
Welborn Clinic
Newburgh, Indiana, 47630
California Professionnal Research
Newport Beach, California, 92660
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Meridian Clinical Research LLC
Omaha, Nebraska, 68134
Winter Park Urology
Orlando, Florida, 32803
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Urology Associates-Rochester
Rochester, New York, 14618
Northern California Research
Sacramento, California, 95831
Salt Lake Research, PLLC
Salt Lake City, Utah, 84107
San Diego Uro Research
San Diego, California, 92103
Medical Center for Clinical Research
San Diego, California, 92108
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Florida Urology Specialists
Sarasota, Florida, 34237
Seattle Urology Research
Seattle, Washington, 98166
Regional Urology, LLC
Shreveport, Louisiana, 71106
Washington University School of Medicine
St Louis, Missouri, 63110
West Coast Clinical Research
Tarzana, California, 91356
Michigan Institute of Urology
Troy, Michigan, 48084
Urological Associates of Bridgeport
Trumbull, Connecticut, 06611
Urology of Virginia
Virginia Beach, Virginia, 23454
Delaware Valley Urology, LLC-Voorhees
Voorhees Township, New Jersey, 08043
Omega Medical Research
Warwick, Rhode Island, 02886
Piedmont Medical Group
Winston-Salem, North Carolina, 27103
Delaware Valley Urology, LLC
Woodlane, New Jersey, 08060
Canada13 sites
The Male / FemaleHealth and Research Center
Barrie, Ontario, L4M 7G1
Dr. Jonathan Giddens
Brampton, Ontario, L6T 4S5
Brantford Urology Research
Brantford, Ontario, N3R 4N3
Guelph Urology Associates
Guelph, Ontario, N1H5J1
Urologic Associates, Urologic Medical Research
Kitchener, Ontario, N2M 5N4
Mor Urology, Inc.
Newmarket, Ontario, L3X 1W1
Dr. Bernard Goldfarb, MD
North Bay, Ontario, P1B 7K8
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1
Dr. John Mahoney
Ottawa, Ontario, K1H 8L6
Allan Abramovitch, MD
Scarborough Village, Ontario, M1S4V5
Anthony Skehan Medicine Professional Corp.
Thunder Bay, Ontario, P7E 6E7
The Male Health Center
Toronto, Ontario, M6A 3B5
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T 5G1
About this study
Official title: 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).
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Cetrorelix Pamoate
- Keywords
- Cetrorelix, BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrorelix PamoateDrug
Also called Cetrorelix pamoate, D-20762, AEZS-102
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
| Study group | Role | What they receive |
|---|---|---|
| Cetrorelix 78 mg | Experimental | Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26. Receives: Drug: Cetrorelix Pamoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670306
- Sponsor's protocol ID
- AEZS-102-Z041
- Acronym
- AEZS-102-Z041
- Status last verified
- Apr 2011
- First submitted
- 22 Apr 2008
- Last updated
- 5 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study
- ClinicalTrials.gov ID
- NCT00670306
- Acronym / sponsor ID
- AEZS-102-Z041 / AEZS-102-Z041
- Conditions
- Benign Prostatic Hypertrophy
- Keywords
- Cetrorelix, BPH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Posted 19 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetrorelix 78 mg | Experimental | Drug: Cetrorelix PamoateDrug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
- Uroflow (max) 5-15mL/sec
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetrorelix PamoateAlso: Cetrorelix pamoate, D-20762, AEZS-102Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2, | Drug | Cetrorelix 78 mg |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
69 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetrorelix Pamoate in people with Benign Prostatic Hypertrophy, run by AEterna Zentaris at 69 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS Change From Baseline (time frame: Baseline and Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.