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European Active Surveillance Study of LCS12

NCT02146950 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 97265

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Contraception

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Center for Epidemiology and Health Research, Germany

    lead OTHER

Principal Investigators

  • Klaas Heinemann, PhD, MD, MSc, MBA · Center for Epidemiology and Health Research Berlin

Eligibility

Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02146950 on ClinicalTrials.gov