Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

757 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-11

Study Completion Date

2018-05-08

Brief Summary

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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)

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Detailed Description

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Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

EV/DNG (Qlaira, BAY86-5027)

Intervention Type DRUG

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

Interventions

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EV/DNG (Qlaira, BAY86-5027)

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

Intervention Type DRUG

Eligibility Criteria

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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