Extension Study Investigating the Long-Term Safety of Degarelix Three-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

NCT00268892

FE200486 CS15A

Details and patient eligibility

About

The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

Full description

The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.

Enrollment: 278 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 is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
• Has successfully completed the main study.

Exclusion Criterion:

• Has been withdrawn from the main study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 3 patient groups

Degarelix 240/240@40(1-3-6-9)

Experimental group

Description:

Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 240/240@60(1-3-6-9)

Experimental group

Description:

Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 240/240@60(1-4-7-10)

Experimental group

Description:

Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix