Clinical Trial: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia (MA0901)

Brief 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.

Detailed Summary:

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.


Sponsor: Bayer

Current Primary Outcome: Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: March 9, 2010
Date Started: April 2009
Date Completion:
Last Updated: April 9, 2012
Last Verified: April 2012