NCT02886598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

2.6 years

First QC Date

August 29, 2016

Last Update Submit

June 14, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Up to 12 months

Study Arms (1)

Firmagon®

Treatment according to standard clinical practice.

Drug: degarelix

Interventions

degarelixDRUG
Also known as: Firmagon®
Firmagon®

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who visit department of Urology in hospitals for treatment of prostate cancer.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Global Clinical Compliance

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 1, 2016

Study Start

September 1, 2016

Primary Completion

March 26, 2019

Study Completion

March 26, 2019

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

KR(1)