MedTrace Logo

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

NCT00663858 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2011-01-17

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • Frans MJ Debruyne, M.D. · Andros Mannenkliniek, Arnhem, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-09-30
Completion
2010-01-31

Countries

  • Belarus
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • North Macedonia
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663858 on ClinicalTrials.gov