Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
NCT ID: NCT03555578
Last Updated: 2025-10-07
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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RECRUITING
1890 participants
OBSERVATIONAL
2017-11-02
2026-04-30
Brief Summary
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Detailed Description
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This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the leuprorelin acetate injection kit 11.25 mg in the routine clinical setting. The planned number of observed patients will be approximately 300.
This multi-center observational 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 11.25 mg
Leuprorelin Acetate Injection Kit 11.25 mg, every 12 weeks subcutaneously, for up to at most 8 years. Participants received interventions as part of routine medical care.
Leuprorelin Acetate
Leuprorelin Acetate Injection Kit
Interventions
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Leuprorelin Acetate
Leuprorelin Acetate Injection Kit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
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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Central Contacts
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Related Links
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Click here for more information about this trial in easy-to-understand language.
Other Identifiers
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JapicCTI-183981
Identifier Type: REGISTRY
Identifier Source: secondary_id
Leuprorelin-5004
Identifier Type: -
Identifier Source: org_study_id
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