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Mirena Post-marketing Surveillance in Japan

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

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

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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.

Clinical Details

Official title: Drug Use Investigation of Mirena

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena

Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena

Secondary outcome:

Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena

Pregnancy rate

Released amount of Levonorgestrel [estimated from removed Mirena]


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Women who are inserted Mirena for intrauterine contraception Exclusion


- Women who are contraindicated based on the product label

Locations and Contacts

Many locations, Japan
Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: May 2007
Last updated: January 8, 2014

Page last updated: August 23, 2015

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