An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

Ferring

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00215683

FE200486 CS12A

Details and patient eligibility

About

This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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 (including one year in the main study).

Full description

Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).

The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

Enrollment: 137 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant)
• Had completed the FE200486 CS12 study

Exclusion criterion:

• Had been withdrawn from the FE200486 CS12 study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 3 patient groups

Degarelix 80 mg

Experimental group

Description:

Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).

Treatment:

Drug: Degarelix

Degarelix 120 mg

Experimental group

Description:

Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).

Treatment:

Drug: Degarelix

Degarelix 160 mg

Experimental group

Description:

Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).

Treatment:

Drug: Degarelix