Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

Ferring

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01215513

FE200486 CS42A

Details and patient eligibility

About

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

Enrollment: 127 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
• Has completed the 7-month main trial, FE200486 CS42

Exclusion criteria

• Has been withdrawn/discontinued from the FE200486 CS42 trial
• A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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127 participants in 1 patient group

Degarelix

Experimental group

Treatment:

Drug: Degarelix