Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
|ClinicalTrials.gov Identifier: NCT03209492|
Recruitment Status : Completed
First Posted : July 6, 2017
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Drug: Leuprorelin acetate|
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.
• Leuprorelin acetate
This multi-center trial will be conducted in Japan.
|Study Type :||Observational|
|Actual Enrollment :||333 participants|
|Official Title:||Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||December 1, 2017|
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.
Drug: Leuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg
Other Name: Leuplin PRO for Injection Kit 22.5 mg
- Percentage of Participants Who Had One or More Adverse Events [ Time Frame: Up to Week 24 ]
- Percentage of Participants Who Had One or More Adverse Reactions [ Time Frame: Up to Week 24 ]Adverse drug reaction refers to adverse events related to the administered drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209492
|Takeda Selected Site|
|Study Director:||Study Director||Takeda|