Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

Bayer757 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

757

Conditions

Contraception

Interventions

EV/DNG (Qlaira, BAY86-5027)DRUG

Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, South Korea

Outcomes

Primary Outcomes

Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)

Time frame: Up to 6 months

Secondary Outcomes

Contraceptive Efficacy by Number of unintended pregnancies

Time frame: From 3 to 6 months

Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number

Time frame: 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

Time frame: From 3 to 6 months

Number of subjects with improved heavy menstrual bleeding

Time frame: From 3 to 6 months

Data from ClinicalTrials.gov

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