Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
Status:
Completed
Trial end date:
2019-12-12
Target enrollment:
Participant gender:
Summary
The primary objective in this study is collecting post-marketing information on the safety.
Thus, it includes information under the routine clinical practice on adverse events (AEs) and
adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the
first 12 months Mirena insertion.
The secondary objective(s) in this study is/are collecting information on Mirena
effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and
dysmenorrhea pain as far as these are recorded under routine clinical practice.