Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
NCT ID: NCT01511874
Last Updated: 2015-09-23
Study Results
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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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ELIGRAD 22.5mg
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
ELIGARD 22.5mg
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Interventions
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ELIGARD 22.5mg
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject with prostate cancer with TNM stage T2\~4NxMx
* Blood testosterone concentration ≥ 100ng/dl
* Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
* WHO ECOG performance status ≤ 2
* Signed written informed consent
Exclusion Criteria
* Brain metastasis
* Another primary malignant tumor except for prostate cancer
* Other conditions which in the opinion of the investigator preclude enrollment into the study
20 Years
MALE
No
Sponsors
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HanAll BioPharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Byung Ha Chung, Medicine
Role: PRINCIPAL_INVESTIGATOR
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Locations
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Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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fr-HE530-01
Identifier Type: -
Identifier Source: org_study_id
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