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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuprorelin Acetate

Drug

Leuplin PRO for Injection Kit 22.5 mg

Other names: Leuplin PRO for Injection Kit 22.5 mg

Primary outcomes

Percentage of Participants Who Had One or More Adverse Events

Time frame: Up to Week 24

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jul 6, 2017
Registry last updated: Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed