Safety and Efficacy of Firmagon® (Degarelix) for Injection

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: degarelix

• Registration Number: NCT02886598
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study Start: 2016-09
• Study First Posted: 2016-09-01
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 368

Inclusion Criteria

• Patients who are eligible for the treatment of Firmagon® (degarelix) for injection according to the approved product label, and Firmagon® (degarelix) treatment decided before study enrolment. Moreover, patient should have not previously received Firmagon® (degarelix) for injection before the study commencement date at each site. - Indication: treatment of advanced, hormone-dependent prostate cancer.

Exclusion Criteria

• Patients with previous or concurrent known hypersensitivity to any component of the drug.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Firmagon®	degarelix	Treatment according to standard clinical practice.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 12 months

Trial Locations

Locations (1)

Gangnam Severance Hospital (there may be other sites in this country); 🇰🇷 Seoul, Korea, Republic of