Mirena Post-marketing Surveillance in Japan
- Registration Number
- NCT01414140
- Lead Sponsor
- Bayer
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 567
Inclusion Criteria
- Women who are inserted Mirena for intrauterine contraception
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Exclusion Criteria
- Women who are contraindicated based on the product label
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Levonorgestrel IUS (Mirena, BAY86-5028) -
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena After Mirera insertion, up to 5 years Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena After Mirera insertion, up to 5 years
- Secondary Outcome Measures
Name Time Method Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena After Mirera insertion, up to 5 years Released amount of Levonorgestrel [estimated from removed Mirena] After Mirera insertion, up to 5 years Pregnancy rate After Mirera insertion, up to 5 years