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Mirena Post-marketing Surveillance in Japan

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01414140
First received: August 10, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of Mirena

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena [ Time Frame: After Mirera insertion, up to 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena [ Time Frame: After Mirera insertion, up to 5 years ] [ Designated as safety issue: Yes ]

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 [ Time Frame: After Mirera insertion, up to 5 years ] [ Designated as safety issue: Yes ]
  • Pregnancy rate [ Time Frame: After Mirera insertion, up to 5 years ] [ Designated as safety issue: No ]
  • Released amount of Levonorgestrel [estimated from removed Mirena] [ Time Frame: After Mirera insertion, up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 567
Study Start Date: May 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Women inserted Mirena for intrauterine contraception.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target population of this study is women who patients who are inserted Mirena for intrauterine contraception. The study is expected to collect data of 550 women.

Criteria

Inclusion Criteria:

  • Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
  • Women who are contraindicated based on the product label
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414140

Locations
Japan
Many locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01414140     History of Changes
Other Study ID Numbers: 15036, MIRENA
Study First Received: August 10, 2011
Last Updated: January 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Mirena, contraception

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 23, 2013