Female Contraception
Conditions
Keywords
Mirena, Contraception, Amenorrhea
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.
Interventions
DRUGLevonorgestrel IUD (Mirena, BAY86-5028)
Women who have been prescribed Mirena in contraception; followed up for 12 months
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of Mirena users who have menstrual disorders | 12 months |
| Proportion of Mirena users with menorrhagia | 12 months |
| Cumulative rate of satisfaction in Mirena users | 12 months |
Countries
Algeria
Outcome results
None listed