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| ID | Type | Description | Link |
|---|---|---|---|
| QL0901 | Other Identifier | Company Internal |
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Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Drug | At the discretion of the attending physician |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities. | up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to event for discontinuation due to reasons other than bleeding irregularities | Month 3-5 | |
| Time to event for discontinuation due to reasons other than bleeding irregularities | Month 6-12 | |
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Inclusion Criteria:
Exclusion Criteria:
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Women in gynecological practice
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Czechia | |||||
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| Progestin Only Pills |
| Drug |
At the discretion of the attending physician |
|
| Number of intracyclic bleeding |
| Month 3-5 |
| Number of intracyclic bleeding | Month 6-12 |
| Number of heavy and/or prolonged bleeding | Month 3-5 |
| Number of heavy and/or prolonged bleeding | Month 6-12 |
| Number of unintended pregnancies | Month 3-5 |
| Number of unintended pregnancies | Month 6-12 |
| Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons | Month 3-5 |
| Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons | Month 6-12 |
| Global assessment of well-being and satisfaction | Month 3-5 |
| Global assessment of well-being and satisfaction | Month 6-12 |
| Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy | up to 12 Months |
| Many Locations |
| France |
| Many Locations | Germany |
| Many Locations | Greece |
| Many Locations | Hungary |
| Many Locations | Israel |
| Many Locations | Italy |
| Many Locations | Russia |
| Many Locations | Slovakia |
| Many Locations | Sweden |
| Many Locations | United Kingdom |