Safety and Efficacy of Firmagon® (Degarelix) for Injection

NCT ID: NCT02886598

Last Updated: 2019-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

368 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-03-26

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Firmagon®

Treatment according to standard clinical practice.

degarelix

Intervention Type DRUG

Interventions

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degarelix

Intervention Type DRUG

Other Intervention Names

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Firmagon®

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Gangnam Severance Hospital (there may be other sites in this country)

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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000260

Identifier Type: -

Identifier Source: org_study_id

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