Clinical Trial: Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion
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 Summary:
Sponsor: Bayer
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: March 13, 2013
Date Started: February 2013
Date Completion:
Last Updated: September 10, 2015
Last Verified: September 2015