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

September 10, 2015 updated by: Bayer

Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who have been prescribed Mirena for contraception.

Description

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

Exclusion Criteria:

  • Nulliparous
  • Pregnancy
  • Mirena's contre-indication
  • Mirena for HMB
  • Abnormal bleeding pattern

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Levonorgestrel IUD (Mirena, BAY86-5028)
Women who have been prescribed Mirena in contraception; followed up for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Mirena users who have at least one period of Amenorrhea of at least three months
Time Frame: 12 months
12 months
Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Mirena users who have menstrual disorders
Time Frame: 12 months
12 months
Proportion of Mirena users with menorrhagia
Time Frame: 12 months
12 months
Cumulative rate of satisfaction in Mirena users
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16314
  • MA1211DZ (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Levonorgestrel IUD (Mirena, BAY86-5028)

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Locations

3
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