Mirena Post-marketing Surveillance in Japan

January 8, 2014 updated by: Bayer

Drug Use Investigation of Mirena

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

567

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Many locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The target population of this study is women who patients who are inserted Mirena for intrauterine contraception. The study is expected to collect data of 550 women.

Description

Inclusion Criteria:

  • Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
  • Women who are contraindicated based on the product label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Women inserted Mirena for intrauterine contraception.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena
Time Frame: After Mirera insertion, up to 5 years
After Mirera insertion, up to 5 years
Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena
Time Frame: After Mirera insertion, up to 5 years
After Mirera insertion, up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena
Time Frame: After Mirera insertion, up to 5 years
After Mirera insertion, up to 5 years
Pregnancy rate
Time Frame: After Mirera insertion, up to 5 years
After Mirera insertion, up to 5 years
Released amount of Levonorgestrel [estimated from removed Mirena]
Time Frame: After Mirera insertion, up to 5 years
After Mirera insertion, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15036
  • MIRENA (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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