Mirena or Conventional Medical Treatment for Menorrhagia
Status:
Completed
Trial end date:
2010-11-01
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 prolonged or heavy menstrual
bleeding (Menorrhagia) under daily-life treatment conditions.
It is planned to conduct the study in about 10 countries with a total of 1000 patients. In
several countries, a comparator group will also be documented.
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.