Status:
COMPLETED
Mirena or Conventional Medical Treatment for Menorrhagia
Lead Sponsor:
Bayer
Conditions:
Menorrhagia
Eligibility:
FEMALE
18-45 years
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 prolonged or heavy menstrual bleeding (Menorrhagia)...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Women between the ages of 18-45 (inclusive) not intending to get pregnant during the next year
- Women complaining of heavy menstrual bleeding over several consecutive cycles
- Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
- Informed consent (where required by laws or regulations)
Exclusion
- The contraindications and warnings of the respective Summary of Product Characteristics (Mirena, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
- Women taking hormone replacement therapy
- Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
- Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
- Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
647 Patients enrolled
Trial Details
Trial ID
NCT00864136
Start Date
November 1 2008
End Date
November 1 2010
Last Update
July 1 2015
Active Locations (8)
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1
Many Locations, China
2
Many Locations, Hong Kong
3
Many Locations, Indonesia
4
Many Locations, Malaysia