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| ID | Type | Description | Link |
|---|---|---|---|
| MA1211DZ | Other Identifier | Company internal |
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MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUD (Mirena, BAY86-5028) | Drug | Women who have been prescribed Mirena in contraception; followed up for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Mirena users who have at least one period of Amenorrhea of at least three months | 12 months | |
| Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Mirena users who have menstrual disorders | 12 months | |
| Proportion of Mirena users with menorrhagia | 12 months | |
| Cumulative rate of satisfaction in Mirena users |
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Inclusion Criteria:
Exclusion Criteria:
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Women who have been prescribed Mirena for contraception.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Algeria |
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| 12 months |
| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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