Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

Prostate Cancer Clinical Trial

Official title:

Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209492
• Other study ID #: Leuprorelin-5002
• Secondary ID: JapicCTI-163213
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: April 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

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.

• Leuprorelin acetate

This multi-center trial will be conducted in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Leuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Had One or More Adverse Events		Up to Week 24
Secondary	Percentage of Participants Who Had One or More Adverse Reactions	Adverse drug reaction refers to adverse events related to the administered drug.	Up to Week 24