Contraception
Conditions
Brief summary
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)
Interventions
Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent * Women after menarche and before menopause * Women requesting contraception or Women diagnosed by a physician as having HMB due to non-organic cause who are also requesting contraception * Women who are prescribed Qlaira® for the first time, during the study period
Exclusion criteria
\- All contraindications according to the local marketing authorization have to be considered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs) | Up to 6 months |
Secondary
| Measure | 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 |
| 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 |
Countries
South Korea
Outcome results
None listed