A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

NCT00451958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2013-03-21

Study results available
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Summary

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Conditions

Interventions

DRUG

Degarelix 80 mg / Degarelix 80 mg

DRUG

Degarelix 160 mg / Degarelix 160 mg

DRUG

Leuprolide 7.5 mg / Degarelix 80 mg

DRUG

Leuprolide 7.5 mg / Degarelix 160 mg

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
2007-03-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

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

Study Locations

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Entities

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 NCT00451958 on ClinicalTrials.gov