Contraception
Conditions
Keywords
Mirena, contraception
Brief 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.
Interventions
Women inserted Mirena for intrauterine contraception.
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women who are inserted Mirena for intrauterine contraception
Exclusion criteria
* Women who are contraindicated based on the product label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena | After Mirera insertion, up to 5 years |
| Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena | After Mirera insertion, up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena | After Mirera insertion, up to 5 years |
| Pregnancy rate | After Mirera insertion, up to 5 years |
| Released amount of Levonorgestrel [estimated from removed Mirena] | After Mirera insertion, up to 5 years |
Countries
Japan
Outcome results
None listed