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Mirena Post-marketing Surveillance in Japan

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ClinicalTrials.gov Identifier: NCT01414140
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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 2007
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
Group 1 Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Women inserted Mirena for intrauterine contraception.



Primary Outcome Measures :
  1. Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena [ Time Frame: After Mirera insertion, up to 5 years ]
  2. 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 :
  1. 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 ]
  2. Pregnancy rate [ Time Frame: After Mirera insertion, up to 5 years ]
  3. Released amount of Levonorgestrel [estimated from removed Mirena] [ Time Frame: After Mirera insertion, up to 5 years ]


Information from the National Library of Medicine

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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.
Criteria

Inclusion Criteria:

  • Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
  • Women who are contraindicated based on the product label

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414140


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01414140     History of Changes
Other Study ID Numbers: 15036
MIRENA ( Other Identifier: Company Internal )
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Bayer:
Mirena, contraception

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