Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
NCT ID: NCT03209518
Last Updated: 2019-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
312 participants
OBSERVATIONAL
2016-03-18
2018-10-10
Brief Summary
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Detailed Description
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This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.
The survey will enroll approximately 300 patients.
\- Leuprorelin
This multi-center survey 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 was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin 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
* Pregnant or potentially pregnant participants and breastfeeding participants
FEMALE
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-163203
Identifier Type: REGISTRY
Identifier Source: secondary_id
Leuprorelin-5003
Identifier Type: -
Identifier Source: org_study_id
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