Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449150
Status:
TERMINATED
Last Update Posted:
2018-08-03
First Post:
2007-03-15
Brief Title:
Cetrorelix CET Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy BPH
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial did not meet primary efficacy endpoint for double blind phase
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None