Benign Prostatic HypertrophyPhase 3NCT00663858
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
A Phase 3 study testing Cetrorelix 78+78 in people with Benign Prostatic Hypertrophy, run by AEterna Zentaris at 54 sites in 10 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+78
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 54 sitesin 10 countries
- Study dates
- Mar 2008to Jan 2010
- 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
54 sites in 10 countries.
54 sites in 10 countries
Czechia9 sites
Privat urological ambulance
Besenov, 25601
Health Center SANUS
Hradec Králové, 500 02
Privat urological ambulance
Pilsen, 323 26
Urocentrum Prague, Out-Patient Clinic of Urology
Prague, 120 00
1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology
Prague, 12808
Urological center Uro-Santé Brumlovka
Prague, 14000
Androgeos Clinic
Prague, 160 00
Policlinic Pod Marjánkou 12, Urological Department
Prague, 169 00
Faculty hospital Na Bulovce
Prague, 18081
Germany9 sites
Pan-Klinik Urologie
Cologne, 50667
Urologische Gemeinschaftspraxis Rulf/Langhorst
Erkrath, 40699
Urologische Praxisgemeinschaft Frankfurt Höchst
Frankfurt, 65929
Urologische Praxis
Marburg, 35039
Urologische Praxis
Münster, 48143
Urologische Klinik, Ev. Krankenhaus Oberhausen
Oberhausen, 46047
Klinikum Offenbach GmbH, Klinik für Urologie
Offenbach, 63069
Asklepios Klinik Seligenstadt
Seligenstadt, 63500
Praxis Filipas
Wiesbaden, 65185
Netherlands9 sites
Gelre Ziekenhuizen
Amsterdam, 1091
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091
Andros Mannenkliniek
Arnhem, 6803 AA
Atrium Medisch Centrum
Heerlen, 6401 CX
Andros Mannenkliniek
Leiden, 2316
Andros Mannenkliniek
Maastricht, 6212 XN
Andros Mannenkliniek
Maastricht, 6212
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6500 GS
Streekziekenhuis Koningin Beatrix
Winterswijk, 7101
Bulgaria5 sites
University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department
Plovdiv, 4000
Aleksandrovska Hospital, Kidney Transplantation Department
Sofia, 1431
Aleksandrovska Hospital, Oncourology Department
Sofia, 1431
National Central Hospital for Active Treatment of Oncology JSC
Sofia, 1756
Multiprofil Hospital "Sveta Anna", Urology Department
Varna, 9000
France5 sites
Hopital Henri Mondor Service Urologie
Créteil, 94000
CHU Hôpital Claude Huriez
Lille, 59037
Hopital Edouard Heriot Service Urologie
Lyon, 69437
Hopital René Dubos Service Urologie 6
Pontoise, 95301
C.H.U Rangueil, Service d'Urologie
Toulouse, 31000
Romania5 sites
S.C. Uro Andro Med Srl
Bucharest, 021336
Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie
Bucharest, 042122
Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"
Bucharest, 050659
Clinica Chirurgie Urologica si Transplant Renal
Bucharest, 22328
Centrul Medical "Sf. Pantelimon"
Pantelimon, 77145
Italy4 sites
University of Bari, Department of Urology
Bari, 70124
Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele
Milan, 20132
Università Federico II Napoli
Naples, 80100
University of Padova, Department of Urology
Padova, 35128
United Kingdom4 sites
Bristol Royal Infirmary, Urology Research Unit
Bristol, BS2 8HW
Leighton Hospital, Clinical Trials Dept., Michael Heal Unit
Crewe, Cheshire, CW1 4QJ
Leicester General Hospital, Urology Section
Leicester, LE5 4PW
Freeman Hospital, Urology Clinic
Newcastle upon Tyne, NE7 7AA
Belarus3 sites
19th Central Regional Policlinic, Urology department
Minsk, 220 023
4th City Hospital
Minsk, 220 036
Minsk Regional Clinical Hospital, Clinic of Urology
Minsk, 223 052
About this study
Official title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study
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).
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Cetrorelix 78+78, Cetrorelix 78 + Placebo, Placebo
- 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+78Drug
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
Cetrorelix 78 + PlaceboDrug
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28
PlaceboOther
Placebo on Week 0, Week 2, Week 26 and Week 28
| Study group | Role | What they receive |
|---|---|---|
| Cetrorelix 78+78 | Experimental | Not described Receives: Drug: Cetrorelix 78+78 |
| Cetrorelix 78 + Placebo | Experimental | Not described Receives: Drug: Cetrorelix 78 + Placebo |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
IPSS score of BPH symptoms 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 overall score range: 0 points (best) to 35 points (worst)
Measured: Baseline and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionJan 2010
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frans MJ Debruyne, M.D., Study chair, Andros Mannenkliniek, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663858
- Sponsor's protocol ID
- AEZS-102-036
- Status last verified
- Dec 2010
- First submitted
- 17 Apr 2008
- Last updated
- 17 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 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: a Double-blind Placebo-controlled Efficacy Study
- ClinicalTrials.gov ID
- NCT00663858
- Acronym / sponsor ID
- AEZS-102-036
- Conditions
- Benign Prostatic Hypertrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 17 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cetrorelix 78+78 | Experimental | Drug: Cetrorelix 78+78 |
| Cetrorelix 78 + Placebo | Experimental | Drug: Cetrorelix 78 + Placebo |
| Placebo | Placebo comparator | Other: Placebo |
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+78Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg) | Drug | Cetrorelix 78+78 |
| Cetrorelix 78 + PlaceboCetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28 | Drug | Cetrorelix 78 + Placebo |
| PlaceboPlacebo on Week 0, Week 2, Week 26 and Week 28 | Other | Placebo |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: Baseline and 52 weeks
IPSS score of BPH symptoms 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 overall score range: 0 points (best) to 35 points (worst)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 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.
Frans MJ Debruyne, M.D. study chair
Andros Mannenkliniek, Arnhem, The Netherlands
54 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetrorelix 78+78 in people with Benign Prostatic Hypertrophy, run by AEterna Zentaris at 54 sites in 10 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: finished, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Czechia, Germany, Netherlands, Bulgaria, France and 5 more countries. 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 17 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 Symptom 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 17 Jan 2011.