Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| QL1212KR | Other Identifier | Company internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Drug | Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Efficacy by Number of unintended pregnancies | From 3 to 6 months | |
| Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number | From 3 to 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- All contraindications according to the local marketing authorization have to be considered.
Not provided
Not provided
Not provided
Not provided
Generally healthy women after menarche and before menopause desiring contraception with or without HMB will be recruited who are determined to start Qlaira
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | South Korea |
Not provided
Not provided
Not provided
Not provided
| The relief of heavy menstrual bleeding symptom also will be calculated as an efficacy variable from admission to the study until final visit by subject's assessment | From 3 to 6 months |
| Number of subjects with improved heavy menstrual bleeding | From 3 to 6 months |