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The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP (BAY86-5300) | Drug | Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP (1 tablet/day); up to 120-day treatment period followed by a 4-day tablet-free interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of bleeding days | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the number of missed tablets between Arms A and B | Approximately 1 year | |
| Bleeding pattern and cycle control parameters | Approximately 1 year | |
| Number of cycles per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| EE20/DRSP/L-5-MTHF (BAY98-7071) | Drug | Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium (1 tablet/day) up to 120-day treatment period followed by a 4-day tablet-free interval |
|
| EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660) | Drug | Day 1-24: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium per tablet (1 tablet/day) Day 25-28: tablets with 0.451 mg levomefolate calcium (1 tablet/day) |
|
| Approximately 1 year |
| ID | Term |
|---|---|
| C005984 | 5-methyltetrahydrofolate |
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