Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
- Registration Number
- NCT03209492
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
- Detailed Description
The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have prostate cancer.
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.
ā¢ Leuprorelin acetate
This multi-center trial will be conducted in Japan.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 333
Inclusion Criteria
- Participants with prostate cancer will be included.
Exclusion Criteria
- Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Leuprorelin acetate 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Had One or More Adverse Events Up to Week 24
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Had One or More Adverse Reactions Up to Week 24 Adverse drug reaction refers to adverse events related to the administered drug.
Trial Locations
- Locations (1)
Takeda Selected Site
šÆšµTokyo, Japan