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Completed

NCT Number: NCT01833793

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

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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Key information

Conditions

Female Contraception Amenorrhea Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Algeria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel IUD (Mirena, BAY86-5028)

Drug

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

Primary outcomes

  1. Proportion of Mirena users who have at least one period of Amenorrhea of at least three months

    Time frame: 12 months

  2. Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users

    Time frame: 12 months

Secondary outcomes

  1. Proportion of Mirena users who have menstrual disorders

    Time frame: 12 months

  2. Proportion of Mirena users with menorrhagia

    Time frame: 12 months

  3. Cumulative rate of satisfaction in Mirena users

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion

Acronym: MARILIA

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 17, 2013
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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