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The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

NCT00295750 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2012-12-19

Study results available
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Summary

The study was a three-arm, active-control, multi-centre, parallel group study.

Conditions

Interventions

DRUG

Degarelix

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.

DRUG

Degarelix

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.

DRUG

Leuprolide 7.5 mg

Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Mexico
  • Netherlands
  • Puerto Rico
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

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 NCT00295750 on ClinicalTrials.gov