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| ID | Type | Description | Link |
|---|---|---|---|
| MA0701 | Other Identifier | Company Internal | |
| MA0901 - non-East Asia | Other Identifier | Company Internal |
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The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.
It is planned to conduct the study in about 10 countries with a total of 1000 patients. In several countries, a comparator group will also be documented.
For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.
The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).
Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697, 14536 (NCT01085487).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
| ||
| Group 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel (Mirena, BAY86-5028) | Drug | Women using Mirena for treatment of menorrhagia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding pattern | at 12 months | |
| Patient satisfaction at end of documentation | at 12 months | |
| Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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Women with a diagnosis of idiopathic menorrhagia can be enrolled after decision for treatment has been made.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23340271 | Derived | Lee BS, Ling X, Asif S, Kraemer P, Hanisch JU, Inki P. Levonorgestrel-releasing intrauterine system versus conventional medical therapy for heavy menstrual bleeding in the Asia-Pacific region. Int J Gynaecol Obstet. 2013 Apr;121(1):24-30. doi: 10.1016/j.ijgo.2012.10.028. Epub 2013 Jan 20. |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Conventional medical treatment |
| Drug |
Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug |
|
| Conventional medical treatment | Drug | Women using anti-fibrinolytic agent for treatment of menorrhagia |
|
| at 12 months |
| Adverse events collection | at 12 months |
| Many Locations |
| Hong Kong |
| Many Locations | Indonesia |
| Many Locations | Malaysia |
| Many Locations | Pakistan |
| Many Locations | South Korea |
| Many Locations | Taiwan |
| Many Locations | Thailand |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |