NCT00378690

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

A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 706 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	leuprorelin acetate	LHRH antagonist

Timeline

• Start date: 2006-03-01
• Primary completion: 2011-06-01
• Completion: 2012-12-01
• First posted: 2006-09-21
• Last updated: 2014-06-04

Locations

71 sites across 10 countries: Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Russia, Slovakia, Spain