A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

NCT00947882 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2015-06-08

Study results available
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Summary

A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

Conditions

  • Lower Urinary Tract Symptoms (LUTS)

Interventions

DRUG

Placebo

Mannitol 50 mg/mL solution

DRUG

Degarelix 10 mg

10 mg degarelix, 40 mg/mL solution

DRUG

Degarelix 20 mg

20 mg degarelix, 40 mg/mL solution

DRUG

Degarelix 30 mg

30 mg degarelix, 40 mg/mL solution

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-03-31
Completion
2011-06-30

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00947882 on ClinicalTrials.gov