Benign Prostatic HypertrophyPhase 3NCT00449150
Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
A Phase 3 study testing Cetrorelix 78 mg + 78 mg and Cetrorelix 78 mg + 52 mg in people with Benign Prostatic Hypertrophy, run by AEterna Zentaris at 68 sites in 4 countries.
Trial 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… 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 78 mg + 78 mg and Cetrorelix 78 mg + 52 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 667 participants
- Where
- 68 sitesin 4 countries
- Study dates
- Mar 2007to Dec 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
Who cannot join
- 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
Trial locations and contacts
68 sites in 4 countries.
68 sites in 4 countries
United States46 sites
Urology Group Of New Mexico
Albuquerque, New Mexico, 87109
Urology Research Options
Aurora, Colorado, 80012
Urologic Oncology
Aurora, Colorado, 80045-0510
South Florida Medical Research
Aventura, Florida, 33180
Medical & Clinical Research Associates
Bay Shore, New York, 11706
Parkhurst Research Oganization Inc.
Bethany, Oklahoma, 73008
Northwestern University Feinberg School of Medecine
Chicago, Illinois, 60611
Tampa Bay Medical Research
Clearwater, Florida, 33761
Southwestern Medical Research Institute
Columbus, Georgia, 31904
Northeast Urology Research
Concord, North Carolina, 28025
Corpus Christi Urology Group
Corpus Christi, Texas, 78404
Urology Clinics of North Texas
Dallas, Texas, 75231
University of Texas Southwestern Medical Center, Department of Urology
Dallas, Texas, 75390-9110
Atlantic Urological Associates
Daytona Beach, Florida, 32114
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Welborn Clinic
Evansville, Indiana, 47713
Urology Group of Westrn Arkansas
Fort Smith, Arkansas, 72901
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
Institute and the Texas Prostate Center
Houston, Texas, 77030
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
South Orange County Medical Research Center
Laguna Hills, California, 92653
Miami VACM
Miami, Florida, 33125-1693
Connecticut Clincal Research Center
Middlebury, Connecticut, 06762
Integrity Medical Research
Mountlake Terrace, Washington, 98043
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Vanderbilt University medical Center
Nashville, Tennessee, 37232
New York University School of Medecine
New York, New York, 10016
University Urology
New York, New York, 10016
California Professionnal Research
Newport Beach, California, 92660
Florida Healthcare Research
Ocala, Florida, 34474
Quality Clinical Research
Omaha, Nebraska, 68114
Kansas City Urology Care
Overland Park, Kansas, 66211
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Hudson Valley Urology
Poughkeepsie, New York, 12601
Michigan Institute of Urology
Saint Clair Shores, Michigan, 48081
Urology San Antonio Research, PA
San Antonio, Texas, 78229
William G. Moseley
San Diego, California, 92103
Florida Urologist Specialists
Sarasota, Florida, 34237
Washington University
St Louis, Missouri, 63110
Metropolitan Urological Specialists
St Louis, Missouri, 63136
Southeastern Research Group
Tallahassee, Florida, 32308
West Coast Clinical Research
Tarzana, California, 91356
Western Clinical Research, Inc.
Torrance, California, 90505
Delaware Valley Urology, LLC
Woodlane, New Jersey, 08060
Canada14 sites
The Male / FemaleHealth and Research Center
Barrie, Ontario, L4M 7G1
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3
Southern Interior Medical Research Inc.
Kelowna, British Columbia, V1Y 2H4
Centre for Advanced Urological Research
Kingston, Ontario, K7L 3J7
Urologic Associates, Urologic Medical Research
Kitchener, Ontario, N2M 5N4
CHUM, Hopital St-Luc
Montreal, Quebec, H2X 3J4
Canada Place Building
North Bay, Ontario, P1B 7K8
The Fe/Male Health Centers
Oakville, Ontario, L6H 3P1
Dynamik Research
Pointe-Claire, Quebec, H9R 3J1
CRCEO
Québec, Quebec, G1R 2J6
Andreou Research Inc.
Surrey, British Columbia, V3V 1N1
University Health Network Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
The Male Health Center
Toronto, Ontario, M6A 3B5
Can-Med Clinical Reserach Inc.
Victoria, British Columbia, V8T 5G1
Germany7 sites
ClinPharm International GmbH Prufzentrum Berlin
Berlin, 12627
ClinPharm International GmbH Prufzentrum Bochum
Bochum, 44787
ClinPharm International GmbH Prufzentrum Dresden
Dresden, 01067
ClinPharm International GmbH Prufzentrum Frankfurt
Frankfurt, 60596
ClinPharm International GmbH Prufzentrum Gorlitz
Görlitz, 02826
ClinPharm International GmbH Prufzentrum Leipzig
Leipzig, 04103
ClinPharm International GmbH Prufzentrum Magdeburg
Magdeburg, 39104
About this study
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
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).
Read the 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.
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Cetrorelix 78 mg + 78 mg, Cetrorelix 78 mg + 52 mg, Placebo
- Keywords
- Cetrorelix
- 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 78 mg + 78 mgDrug
Also called CET, AEZS-102
Cetrorelix 78 mg + 52 mgDrug
Also called CET, AEZS-102
PlaceboDrug
Also called Placebo (PLA)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A: CET 78 mg + 78 mg | Experimental | 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. Receives: Drug: Cetrorelix 78 mg + 78 mg |
| Treatment Group B: CET 78 mg + 52 mg | Experimental | 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. Receives: Drug: Cetrorelix 78 mg + 52 mg; Drug: Placebo |
| Treatment Group C: Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 52 weeks
Secondary outcomes (1)
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.
Measured: Quality of life assessment in the following weeks: 4,12,26,30,38,46,52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionDec 2009
Why it stopped: Trial did not meet primary efficacy endpoint for double blind phase.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Hebert Lepor, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449150
- Sponsor's protocol ID
- Z033
- Status last verified
- Jun 2011
- First submitted
- 15 Mar 2007
- Last updated
- 3 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00449150
- Acronym / sponsor ID
- Z033
- Conditions
- Benign Prostatic Hypertrophy
- Keywords
- Cetrorelix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial did not meet primary efficacy endpoint for double blind phase.
- Enrolment
- 667 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Mar 2007 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A: CET 78 mg + 78 mg | Experimental | Drug: Cetrorelix 78 mg + 78 mgTreatment 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 Group B: CET 78 mg + 52 mg | Experimental | Drug: Cetrorelix 78 mg + 52 mg, Drug: PlaceboTreatment 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 Group C: Placebo | Placebo comparator | Drug: PlaceboTreatment 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
Key exclusion criteria (6 listed)
- 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
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 78 mg + 78 mgAlso: CET, AEZS-102 | Drug | Treatment Group A: CET 78 mg + 78 mg |
| Cetrorelix 78 mg + 52 mgAlso: CET, AEZS-102 | Drug | Treatment Group B: CET 78 mg + 52 mg |
| PlaceboAlso: Placebo (PLA) | Drug | Treatment Group B: CET 78 mg + 52 mg, Treatment Group C: Placebo |
Primary outcome
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)
1 secondary outcome
Time Course of Quality of Life
Time frame: Quality of life assessment in the following weeks: 4,12,26,30,38,46,52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- 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.
Dr. Hebert Lepor, MD principal investigator
NYU Langone Health
68 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetrorelix 78 mg + 78 mg and Cetrorelix 78 mg + 52 mg in people with Benign Prostatic Hypertrophy, run by AEterna Zentaris at 68 sites in 4 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Canada, Germany, Bulgaria. 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. Some participants in this study may receive a placebo. 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?
International Prostate Symptoms Score (IPSS) (time frame: Baseline and 52 weeks). 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 3 Aug 2018.