Mirena Post-marketing Surveillance in Japan

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Levonorgestrel

Criteria

Inclusion Criteria:

• Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:

• Women who are contraindicated based on the product label