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

Bayer35 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Female Contraception

Interventions

Levonorgestrel IUD (Mirena, BAY86-5028)DRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Many Locations, Algeria

Outcomes

Primary Outcomes

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

Time frame: 12 months

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

Time frame: 12 months

Secondary Outcomes

Proportion of Mirena users who have menstrual disorders

Time frame: 12 months

Proportion of Mirena users with menorrhagia

Time frame: 12 months

Cumulative rate of satisfaction in Mirena users

Time frame: 12 months

Data from ClinicalTrials.gov

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