Mirena Post-marketing Surveillance in Japan

Bayer

Status: Completed

Conditions: Contraception

Treatments: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Study type: Observational

Funder types: Industry

Identifiers

NCT01414140

MIRENA (Other Identifier)

15036

Details and patient eligibility

About

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.

Enrollment: 567 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

567 participants in 1 patient group

Group 1

Treatment:

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)