Mirena Post-marketing Surveillance in Japan

NCT ID: NCT01414140

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

567 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Levonorgestrel IUS (Mirena, BAY86-5028)

Intervention Type DRUG

Women inserted Mirena for intrauterine contraception.

Interventions

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Levonorgestrel IUS (Mirena, BAY86-5028)

Women inserted Mirena for intrauterine contraception.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Women who are contraindicated based on the product label
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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MIRENA

Identifier Type: OTHER

Identifier Source: secondary_id

15036

Identifier Type: -

Identifier Source: org_study_id

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