Skip to content

Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT03209518 (opens ClinicalTrials.gov in a new tab)Other idLeuprorelin-5003Other idJapicCTI-163203
Open at ClinicalTrials.govAsk about this trial

Overview

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

Japan

Start
18 Mar 2016
Primary completion
10 Oct 2018
Completion
10 Oct 2018
First posted
6 Jul 2017
Last update posted
1 Nov 2019
Conditions
Premenopausal Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph –

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

    NCT03209518

    18 Mar 2016 to 10 Oct 2018

Registry summary

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

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

Interventions

  • Leuprorelin acetateDrug

Arms1

  • Other

    Leuprorelin acetate

    Usually, 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 Leuprorelin 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 mg6.45
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 mg5.48

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 Leuprorelin as part of routine medical care.0 / 3100 / 31020 / 310

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
Female
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.