MiCo - Mirena or Conventional Medical Treatment for Menorrhagia
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
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.