Mirena Post-marketing Surveillance in Japan

Contraception Clinical Trial

Official title:

Drug Use Investigation of Mirena

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414140
• Other study ID #: 15036
• Secondary ID: MIRENA
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: January 8, 2014
• Start date: May 2007
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Women who are contraindicated based on the product label

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUS (Mirena, BAY86-5028)
Women inserted Mirena for intrauterine contraception.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena		After Mirera insertion, up to 5 years	Yes
Primary	Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena		After Mirera insertion, up to 5 years	Yes
Secondary	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	Yes
Secondary	Pregnancy rate		After Mirera insertion, up to 5 years	No
Secondary	Released amount of Levonorgestrel [estimated from removed Mirena]		After Mirera insertion, up to 5 years	No

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