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Trial · Observational

CompletedPhase not statedResults postedRegistry data

Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

NCTNCT03209492 (opens ClinicalTrials.gov in a new tab)Other idLeuprorelin-5002Other idJapicCTI-163213
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
333 participants (actual)
Sponsor
Takeda · Industry
Design
Not stated
Countries
1 country

Japan

Start
1 Apr 2016
Primary completion
1 Dec 2017
Completion
1 Dec 2017
First posted
6 Jul 2017
Last update posted
11 Apr 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph –

    Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

    NCT03209492

    1 Apr 2016 to 1 Dec 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

Interventions

  • Leuprorelin acetateDrug

Arms1

  • Other

    Leuprorelin acetate

    Usually, for adults, 22.5 mg of leuprorelin acetate is subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants will receive interventions as part of routine medical care.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Up to Week 24

Secondary outcomes(1)

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

    Time frame · Up to Week 24

    Registry description

    Adverse drug reaction refers to adverse events related to the administered drug.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to Week 24

Percentage of Participants Who Had One or More Adverse Events

GroupValue (Percentage of Participants)
Leuprorelin Acetate 22.5 mg4.27
Secondary and other outcome results(1)
Secondary outcomeNumber· Up to Week 24

Percentage of Participants Who Had One or More Adverse Reactions

GroupValue (Percentage of Participants)
Leuprorelin Acetate 22.5 mg2.74

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Leuprorelin Acetate 22.5 mgUsually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.4 / 3284 / 3286 / 328

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participants with prostate cancer will be included. Exclusion Criteria: * Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives

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