Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-05-31

Brief Summary

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MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.

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Detailed Description

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Conditions

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Female Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Levonorgestrel IUD (Mirena, BAY86-5028)

Intervention Type DRUG

Women who have been prescribed Mirena in contraception; followed up for 12 months

Interventions

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Levonorgestrel IUD (Mirena, BAY86-5028)

Women who have been prescribed Mirena in contraception; followed up for 12 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19-40 years at the time of Mirena IUD insertion
* Using Mirena only for contraception indication
* Never having used the product before
* No heavy menstrual bleeding diagnosed
* Have signed informed consent to participate in this study