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| ID | Type | Description | Link |
|---|---|---|---|
| VS1310KR | Other Identifier | company internal |
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The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dienogest (Visanne, BAY86-5258) | Drug | Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population | 6 months and 1 year | |
| Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit). | 6 months and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
- All contraindications according to the local marketing authorization have to be considered.
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Women desiring treatment for endometriosis using Visanne (dienogest 2mg)
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | South Korea |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C023635 | dienogest |
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| D000091662 | Genital Diseases |