NCT00670306

Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)

Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DRUG	Cetrorelix Pamoate	Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-05-01
• Last updated: 2011-04-05
• Results posted: 2011-01-19

Locations

69 sites across 2 countries: United States, Canada