NCT01414140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

5.4 years

First QC Date

August 10, 2011

Last Update Submit

January 8, 2014

Conditions

Contraception

Keywords

Mirena, contraception

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena

    After Mirera insertion, up to 5 years

  • Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena

    After Mirera insertion, up to 5 years

Secondary Outcomes (3)

  • 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

  • Pregnancy rate

    After Mirera insertion, up to 5 years

  • Released amount of Levonorgestrel [estimated from removed Mirena]

    After Mirera insertion, up to 5 years

Study Arms (1)

Group 1

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Interventions

Levonorgestrel IUS (Mirena, BAY86-5028)DRUG

Women inserted Mirena for intrauterine contraception.

Group 1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • Women who are contraindicated based on the product label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

May 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

JP(1)