Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
- Registration Number
- NCT01833793
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Levonorgestrel IUD (Mirena, BAY86-5028) -
- Primary Outcome Measures
Name Time Method Proportion of Mirena users who have at least one period of Amenorrhea of at least three months 12 months Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users 12 months
- Secondary Outcome Measures
Name Time Method Proportion of Mirena users with menorrhagia 12 months Cumulative rate of satisfaction in Mirena users 12 months Proportion of Mirena users who have menstrual disorders 12 months