NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142560

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedProstate cancer
Date of first enrollment13/10/2005
Target sample size10000
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Leuplin SR 11.25 mg Injection Kit (leuprorelin acetate) Dosage And administration of the intervention : 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. Control intervention name : null

Outcome(s)

Primary OutcomeFrequency of adverse drug reactions Primary timeframe: For 96 weeks Frequency, seriousness, and time to onset of adverse events are tabulated by symptom. Adverse events are defined as all unfavorable and unintended signs, symptoms or diseases temporally associated with the use of the medicinal product reported during the period from the first to the last dose of Leuplin SR 11.25 mg Injection Kit. Among these, events which are considered possibly related to the study drug are defined as adverse drug reactions.
Secondary OutcomeProgression-free survival, metastasis-free survival, disease-specific survival, and overall survival Secondary timeframe: From baseline to 96 weeks of treatment Progression-free survival, metastasis-free survival, disease-specific survival, and overall survival from baseline until 96 weeks of treatment with Leuplin SR 11.25 mg Injection Kit are estimated using the Kaplan-Meier method.

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaProstate cancer patients who meet all the following criteria: 1. Patients for whom prostate cancer was initially diagnosed on or after January 1, 2005 2. Patients with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, patients with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey ) 3. Patients with prostate-specific antigen (PSA) level determined at baseline or within 3 months prior to the start of treatment with Leuplin SR 11.25 mg Injection Kit
Exclude criteria

Related Information

Contact

public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation
scientific contact
Name Takeda Pharmaceutical Company Limited Post Marketing Surveillance, Pharm(continued to "Affiliation")
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation acovigilance Department, Takeda Development Center Japan