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OpenTrials
Completed

NCT Number: NCT03209518

Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.

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Key information

Conditions

Premenopausal Breast Cancer

Sex eligibility

Female

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

About this study

The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.

This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.

The survey will enroll approximately 300 patients.

  • Leuprorelin

This multi-center survey 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 premenopausal breast cancer will be included.

Exclusion criteria

  • Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
  • Pregnant or potentially pregnant participants and breastfeeding participants

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

  1. Percentage of Participants Who Had One or More Adverse Events

    Time frame: Up to Week 24

Secondary outcomes

  1. 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

Official study title

Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2017
Registry last updated
Nov 1, 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.

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