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Trial record 12 of 69 for:    pelvic inflammatory disease AND (woman OR women OR female)

Mirena Post-marketing Surveillance in Japan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414140
First Posted: August 11, 2011
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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:


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.

  Eligibility

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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01414140     History of Changes
Other Study ID Numbers: 15036
MIRENA ( Other Identifier: Company Internal )
First Submitted: August 10, 2011
First Posted: August 11, 2011
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