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P021

Peptide 021, GLXC-21260

Quick Stats
Studies 37
Trials 57
Completed OBSERVATIONAL NCT02167893

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.

Detailed Description

This survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer participants in daily medical practice. For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Interventions

Name: Leuprorelin acetate
Type: DRUG
Description: Leuprorelin acetate SR 11.25 mg injection kit

Primary Outcomes

Measure: Number of Participants Reporting One or More Adverse Drug Reactions
TimeFrame: Baseline up to Week 96
Description: Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions
TimeFrame: Baseline up to Week 96
Description: Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Trial Information

NCT ID

NCT02167893

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Takeda

Last Updated

December 15, 2025