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| ID | Type | Description | Link |
|---|---|---|---|
| MA0801 | Other Identifier | company internal | |
| 14239 | Other Identifier | company internal | |
| 14177 | Other Identifier | company internal | |
| 14176 | Other Identifier | company internal | |
| 14016 | Other Identifier | company internal |
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The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUS (Mirena, BAY86-5028) | Drug | Patients under daily life treatment receiving Mirena according to local drug information. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuation rate | At 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Continuation rate | At 12 months | |
| Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient) | Initial and after 3, 6, 12 and 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 20-35 years switching from short-acting hormonal contraception
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | France | |||||
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| C044815 | etonogestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Implanon (Etonogestrel) | Drug | Patients under daily life treatment receiving Implanon according to local drug information. |
|
| Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons |
| At 24 months |
| Incidence of Adverse Events, Serious Adverse Events | During 24 months |
| The return to fertility of women discontinuing the method for wish for pregnancy | 12 months after discontinuation |
| Many Locations |
| Ireland |
| Many Locations | Slovakia |
| Many Locations | United Kingdom |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |