Active — Not RecruitingNot Applicable

European Active Surveillance Study of LCS12

Germany97,265 participantsStarted 2014-06-17

Plain-language summary

This study is designed to investigate whether LCS12 is associated with an increased risk of unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy, uterine perforation, and PID) associated with the use of LCS12 compared with the established hormonal IUD Mirena, and compared with established copper IUDs during standard clinical practice. In addition, drug utilization patterns will be described.

Who can participate

Age range39 Years

SexFEMALE

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Inclusion Criteria: * Women aged below 40 years who have a new IUD inserted (LCS12, Kyleena, Mirena, copper IUD, or any other hormonal IUD) * Women who are willing to participate in the active surveillance Exclusion Criteria: * Women aged 40 or older at insertion day * Women who are currently enrolled in an interventional trial on IUD use can not participate

What they're measuring

Contraceptive failure (LCS12 vs. Mirena and copper IUDs)

Timeframe: within 3 years

Trial details

NCT IDNCT02146950

SponsorCenter for Epidemiology and Health Research, Germany

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Contraception trials