This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.
Study Type
OBSERVATIONAL
Enrollment
1,125
One group
Unnamed facility
Many Locations, Bulgaria
Unnamed facility
Many Locations, Croatia
Unnamed facility
Many Locations, India
Unnamed facility
Many Locations, Jordan
To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
Time frame: At vist 1 and 4
Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study
Time frame: Every visit
The health-related quality of life questionnaire SF-36 at Visits 1 and 4
Time frame: Visit 1 and 4
The user satisfaction as recorded at Visit 4
Time frame: visit 4
Adverse reactions recorded in an ongoing way throughout the duration of the study
Time frame: every visit
Laboratory parameters as measured at Visits 1 and 4
Time frame: visit 1 and 4
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Unnamed facility
Many Locations, Kuwait
Unnamed facility
Many Locations, Pakistan
Unnamed facility
Many Locations, Romania
Unnamed facility
Many Locations, Russia
Unnamed facility
Many Locations, Saudi Arabia
Unnamed facility
Many Locations, Serbia
...and 3 more locations