CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 528 enrolled
Drug / intervention
Cetrorelix Pamoatedrug
Likely dose
Cetrorelix Pamoate 52 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00670306
NCT00670306Phase 3Completed
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Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study

AEterna Zentaris·interventional·Posted May 1, 2008·Updated Apr 5, 2011

In Brief

A Phase 3 clinical trial evaluating Cetrorelix Pamoate for Benign Prostatic Hypertrophy. Completed, enrolled 528 participants across 69 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hypertrophy
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 1, 2008
Enrollment StartMar 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.2 years ago

Interventions

Cetrorelix Pamoatedrug

Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,