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

NCT ID: NCT01215513

Last Updated: 2013-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Degarelix

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Interventions

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Degarelix

Intervention Type DRUG

Eligibility Criteria

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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* Has been withdrawn/discontinued from the FE200486 CS42 trial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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals Korea, Ltd.

OTHER

Sponsor Role collaborator

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Korea University Hospital

Seoul, Anam-dong, Seongbuk-gu, South Korea

Site Status

Seoul St. Mary's Hospital

Seoul, Banpo-dong, Seocho-gu, South Korea

Site Status

Kyoungbuk National University Hospital

Daegu, Daegu, South Korea

Site Status

Yonsei University Health System Gangnam Sevrance

Seoul, Eonguro, Gangnam-gu, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Hallym University Sacred Heart Hospital

Pyungchon, Gyunggi-do, South Korea

Site Status

Pusan National University Yangsan Hospital

Mulgeum-eup, Gyungnam, South Korea

Site Status

Samsung Medical Center

Seoul, Ilwon-dong, Kangnam-gu, South Korea

Site Status

Asan Medical Center

Seoul, Pungnap-2-dong, Songpa-gu, South Korea

Site Status

Yonsei University Health System (Sevrance Hospital)

Seoul, Seongsanno, Seodaemun-gu, South Korea

Site Status

Seoul National University Hospital

Seoul, Yeongeon-dong, Chongno-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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FE200486 CS42A

Identifier Type: -

Identifier Source: org_study_id

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