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OpenTrials
Completed

NCT Number: NCT01797809

Qlaira rPMS (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)

Completed

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Key information

Conditions

Contraception

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027)

Drug

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

Primary outcomes

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

    Time frame: Up to 6 months

Secondary outcomes

  1. Contraceptive Efficacy by Number of unintended pregnancies

    Time frame: From 3 to 6 months

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

    Time frame: From 3 to 6 months

  3. 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

  4. Number of subjects with improved heavy menstrual bleeding

    Time frame: From 3 to 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Qlaira® Regulatory Post Marketing Surveillance Study in Korea

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2013
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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