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Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

NCT00117312 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2011-05-23

Study results available
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Summary

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued.

Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

Conditions

Interventions

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

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
2002-10-31
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • United States

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 NCT00117312 on ClinicalTrials.gov