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Mirena Post-marketing Surveillance in Japan

NCT01414140 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 567

Last updated 2014-01-09

No results posted yet for this study

Summary

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.

Conditions

  • Contraception

Interventions

DRUG

Levonorgestrel IUS (Mirena, BAY86-5028)

Women inserted Mirena for intrauterine contraception.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Japan

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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 NCT01414140 on ClinicalTrials.gov