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| ID | Type | Description | Link |
|---|---|---|---|
| MIRENA | Other Identifier | Company Internal |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUS (Mirena, BAY86-5028) | Drug | Women inserted Mirena for intrauterine contraception. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 | After Mirera insertion, up to 5 years | |
| Pregnancy rate | After Mirera insertion, up to 5 years |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Japan |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Released amount of Levonorgestrel [estimated from removed Mirena] | After Mirera insertion, up to 5 years |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |