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 Type
OBSERVATIONAL
Enrollment
567
Women inserted Mirena for intrauterine contraception.
Unnamed facility
Many Locations, Japan
Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena
Time frame: 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
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
Pregnancy rate
Time frame: After Mirera insertion, up to 5 years
Released amount of Levonorgestrel [estimated from removed Mirena]
Time frame: After Mirera insertion, up to 5 years
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