Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) (AEZS-102-Z041)
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|ClinicalTrials.gov Identifier: NCT00670306|
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : January 19, 2011
Last Update Posted : April 5, 2011
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).
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hypertrophy||Drug: Cetrorelix Pamoate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||528 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Experimental: Cetrorelix 78 mg
Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Drug: Cetrorelix Pamoate
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
Other Name: Cetrorelix pamoate, D-20762, AEZS-102
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670306
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