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Completed

NCT Number: NCT01414140

Mirena Post-marketing Surveillance in Japan

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.

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Key information

Conditions

Contraception

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
  • Women who are contraindicated based on the product label

Treatment and study plan

Levonorgestrel IUS (Mirena, BAY86-5028)

Drug

Women inserted Mirena for intrauterine contraception.

Primary outcomes

  1. Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena

    Time frame: After Mirera insertion, up to 5 years

  2. Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena

    Time frame: After Mirera insertion, up to 5 years

Secondary outcomes

  1. Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena

    Time frame: After Mirera insertion, up to 5 years

  2. Pregnancy rate

    Time frame: After Mirera insertion, up to 5 years

  3. Released amount of Levonorgestrel [estimated from removed Mirena]

    Time frame: After Mirera insertion, up to 5 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation of Mirena

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
Jan 9, 2014

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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