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Safety and Efficacy of Firmagon® (Degarelix) for Injection

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02886598
Collaborator
(none)
368
Enrollment
1
Location
30.8
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
368 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Firmagon® (Degarelix) for Injection
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Mar 26, 2019
Actual Study Completion Date :
Mar 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Firmagon®

Treatment according to standard clinical practice.

Drug: degarelix
Other Names:
  • Firmagon®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangnam Severance Hospital (there may be other sites in this country) Seoul Korea, Republic of

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02886598
    Other Study ID Numbers:
    • 000260
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Jun 17, 2019
    Last Verified:
    Jun 1, 2019
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jun 17, 2019