Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

Ferring

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117286

FE200486 CS14A

Details and patient eligibility

About

This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years.

Full description

Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.

Enrollment: 57 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
• Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

• Has been withdrawn from the FE200486 CS14 study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Degarelix (60 mg to 160 mg)

Experimental group

Description:

Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

Treatment:

Drug: Degarelix

Degarelix (80 mg to 160 mg)

Experimental group

Description:

Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

Treatment:

Drug: Degarelix