NCT00663858

Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Benign Prostatic Hypertrophy

Interventions

Type	Name	Description
DRUG	Cetrorelix 78+78	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)
DRUG	Cetrorelix 78 + Placebo	Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28
OTHER	Placebo	Placebo on Week 0, Week 2, Week 26 and Week 28

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-09-01
• Completion: 2010-01-01
• First posted: 2008-04-22
• Last updated: 2011-01-17
• Results posted: 2011-01-17

Locations

54 sites across 10 countries: Belarus, Bulgaria, Czechia, France, Germany, Italy, Netherlands, North Macedonia, Romania, United Kingdom