MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Completed

• Conditions: Idiopathic Menorrhagia
• Interventions: Drug: Levonorgestrel (Mirena, BAY86-5028); Drug: Hormonal treatment; Drug: Antifibrinolytic treatment

• Registration Number: NCT01085487
• Lead Sponsor: Bayer

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 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 pools as well as in a global pool. The trial alias are IMPACT Nos. 14697 (NCT00864136), 14536.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Study Completion: 2011-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-09
• Last Update Posted: 2012-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1211

Inclusion Criteria

• Women between the ages of 18-45 (inclusive) not intending to become 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel (Mirena, BAY86-5028)	-
Group 2	Hormonal treatment	-
Group 3	Antifibrinolytic treatment	-

Primary Outcome Measures

Name	Time	Method
Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia	12 months

Secondary Outcome Measures

Name	Time	Method
Bleeding pattern	12 months
Patient satisfaction at end of documentation	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.)	12 months
Safety profile (adverse events)	12 months