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| ID | Type | Description | Link |
|---|---|---|---|
| MA0501 |
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This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.
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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 | One group |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena | At vist 1 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study | Every visit | |
| The health-related quality of life questionnaire SF-36 at Visits 1 and 4 | Visit 1 and 4 |
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Inclusion Criteria:
Exclusion Criteria:
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Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Bulgaria | |||||
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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Serum
| The user satisfaction as recorded at Visit 4 | visit 4 |
| Adverse reactions recorded in an ongoing way throughout the duration of the study | every visit |
| Laboratory parameters as measured at Visits 1 and 4 | visit 1 and 4 |
| Many Locations |
| Croatia |
| Many Locations | India |
| Many Locations | Jordan |
| Many Locations | Kuwait |
| Many Locations | Pakistan |
| Many Locations | Romania |
| Many Locations | Russia |
| Many Locations | Saudi Arabia |
| Many Locations | Serbia |
| Many Locations | Sri Lanka |
| Many Locations | Turkey (Türkiye) |
| Many Locations | United Arab Emirates |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |