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

Female Contraception Clinical Trial

— MARILIA  

Official title:

Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833793
• Other study ID #: 16314
• Secondary ID: MA1211DZ
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: September 10, 2015
• Start date: February 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Algeria: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amenorrhea
• Female Contraception

Intervention

Drug:
• Levonorgestrel IUD (Mirena, BAY86-5028)
Women who have been prescribed Mirena in contraception; followed up for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Mirena users who have at least one period of Amenorrhea of at least three months		12 months	No
Primary	Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users		12 months	No
Secondary	Proportion of Mirena users who have menstrual disorders		12 months	No
Secondary	Proportion of Mirena users with menorrhagia		12 months	No
Secondary	Cumulative rate of satisfaction in Mirena users		12 months	No

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