Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea
Completed
- Conditions
- Contraception
- Interventions
- Drug: EV/DNG (Qlaira, BAY86-5027)
- Registration Number
- NCT01797809
- Lead Sponsor
- Bayer
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 757
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
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Exclusion Criteria
- All contraindications according to the local marketing authorization have to be considered.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 EV/DNG (Qlaira, BAY86-5027) -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs) Up to 6 months
- Secondary Outcome Measures
Name Time Method 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