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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Female Contraception

Intervention: Levonorgestrel IUD (Mirena, BAY86-5028) (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

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

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

Secondary outcome:

Proportion of Mirena users who have menstrual disorders

Proportion of Mirena users with menorrhagia

Cumulative rate of satisfaction in Mirena users

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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 and Contacts

Many Locations, Algeria
Additional Information

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Starting date: February 2013
Last updated: May 27, 2015

Page last updated: August 23, 2015

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