Mirena Post-marketing Surveillance in Japan
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT01414140
Collaborator
(none)
567
1
65.1
8.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
567 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Drug Use Investigation of Mirena
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
Oct 1, 2012
Actual Study Completion Date
:
Oct 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1
|
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Women inserted Mirena for intrauterine contraception.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
-
Women who are contraindicated based on the product label
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Japan |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT01414140
Other Study ID Numbers:
- 15036
- MIRENA
First Posted:
Aug 11, 2011
Last Update Posted:
Jan 9, 2014
Last Verified:
Jan 1, 2014