Overview
Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
Status:
Completed
Completed
Trial end date:
2015-05-01
2015-05-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
BayerTreatments:
Levonorgestrel
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