Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
NCT ID: NCT03209492
Last Updated: 2019-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
333 participants
OBSERVATIONAL
2016-04-01
2017-12-01
Brief Summary
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Detailed Description
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This study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
The study will enroll approximately 300 patients.
• Leuprorelin acetate
This multi-center trial will be conducted in Japan.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Leuprorelin acetate
Usually, for adults, 22.5 mg of leuprorelin acetate is subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants will receive interventions as part of routine medical care.
Leuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg
Interventions
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Leuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
MALE
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Takeda Selected Site
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JapicCTI-163213
Identifier Type: REGISTRY
Identifier Source: secondary_id
Leuprorelin-5002
Identifier Type: -
Identifier Source: org_study_id
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