The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.
The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World). Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697 (NCT00864136), 14536.
Study Type
OBSERVATIONAL
Enrollment
1,211
Women using Mirena for treatment of menorrhagia
Hormonal treatment (including combined oral contraceptives or oral or injectable progestogens)
Antifibrinolytic treatment (such as tranexamic acid)
Unnamed facility
Many Locations, Albania
Unnamed facility
Many Locations, Bosnia and Herzegovina
Unnamed facility
Many Locations, Colombia
Unnamed facility
Many Locations, Croatia
Unnamed facility
Many Locations, Czechia
Unnamed facility
Many Locations, Jordan
Unnamed facility
Many Locations, Lebanon
Unnamed facility
Many Locations, Moldova
Unnamed facility
Many Locations, North Macedonia
Unnamed facility
Many Locations, Romania
...and 4 more locations
Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia
Time frame: 12 months
Bleeding pattern
Time frame: 12 months
Patient satisfaction at end of documentation
Time frame: 12 months
Impact of the therapy in terms of patient-reported health outcomes assessed using a validated questionnaire (Shaw RW et. al., British Journal of Obstetrics and Gynaecology, Vol 105(11), 1998.)
Time frame: 12 months
Safety profile (adverse events)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.