Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

April 5, 2019 updated by: Bayer

Qlaira® Regulatory Post Marketing Surveillance Study in Korea

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

757

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Generally healthy women after menarche and before menopause desiring contraception with or without HMB will be recruited who are determined to start Qlaira

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: EV/DNG (Qlaira, BAY86-5027)
Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Contraceptive Efficacy by Number of unintended pregnancies
Time Frame: From 3 to 6 months
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
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
From 3 to 6 months
Number of subjects with improved heavy menstrual bleeding
Time Frame: From 3 to 6 months
From 3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2013

Primary Completion (Actual)

January 16, 2018

Study Completion (Actual)

May 8, 2018

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 16344
  • QL1212KR (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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