Special drug use surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal breast cancer"

Special drug use surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal breast cancer"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223148

Enrollment

312

Registered

2016-03-16

Start date

2016-03-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenopausal breast cancer

Interventions

investigational material(s) Generic name etc : Leuprorelin INN of investigational material : Leuprorelin Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Participants with premenopausal breast cancer will be included.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria will not be included. 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

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants Who Had One or More Adverse Events Time Frame: Up to Week 24	—

Secondary

Measure	Time frame
safety Percentage of Participants Who Had One or More Adverse Reactions Time Frame: Up to Week 24	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026