Prostate cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Leuplin PRO for Injection Kit 22.5 mg
INN of investigational material :
Therapeutic category code : 249 Other hormone preparations (including antihormon
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Participants with prostate cancer will be included.
Exclusion criteria
Exclusion criteria: Participants who meet the following criteria will not be included. -Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who had one or more adverse events Time frame is defined the duration from the start of treatment with Leuprorelin acetate injection up to 24 weeks after the start of treatment (or at the time the observation is discontinued). Timeframe: Up to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who had one or more adverse drug reactions Adverse drug reaction refers to adverse events related to administered drug. Time frame is defined the duration from the start of treatment with Leuprorelin acetate injection up to 24 weeks after the start of treatment (or at the time the observation is discontinued). Timeframe: Up to Week 24 | — |
Outcome results
None listed