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Trial record 11 of 110 for:    pelvic inflammatory disease AND (woman OR women OR female)

Mirena Post-marketing Surveillance in Japan

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: August 10, 2011
Last updated: January 8, 2014
Last verified: January 2014
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
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:

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 ]
  • Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena [ Time Frame: 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 [ Time Frame: After Mirera insertion, up to 5 years ]
  • Pregnancy rate [ Time Frame: After Mirera insertion, up to 5 years ]
  • Released amount of Levonorgestrel [estimated from removed Mirena] [ Time Frame: After Mirera insertion, up to 5 years ]

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.

Inclusion Criteria:

  • Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
  • Women who are contraindicated based on the product label
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01414140

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

Additional Information:
Responsible Party: Bayer Identifier: NCT01414140     History of Changes
Other Study ID Numbers: 15036
MIRENA ( Other Identifier: Company Internal )
Study First Received: August 10, 2011
Last Updated: January 8, 2014

Keywords provided by Bayer:
Mirena, contraception

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral processed this record on April 28, 2017