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A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD

NCT00378690 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 706

Last updated 2014-06-04

No results posted yet for this study

Summary

Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.

Conditions

Interventions

DRUG

leuprorelin acetate

LHRH antagonist

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Central Contact · Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2011-06-30
Completion
2012-12-31

Countries

  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Russia
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT00378690 on ClinicalTrials.gov