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

Premenopausal Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209518
• Other study ID #: Leuprorelin-5003
• Secondary ID: JapicCTI-163203
• Status: Completed
• Start date: March 18, 2016
• Est. completion date: October 10, 2018

Study information

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

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Premenopausal Breast Cancer

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