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MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01085487
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : April 10, 2012
Information provided by:

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.

Condition or disease Intervention/treatment
Idiopathic Menorrhagia Drug: Levonorgestrel (Mirena, BAY86-5028) Drug: Hormonal treatment Drug: Antifibrinolytic treatment

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.

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Study Type : Observational
Actual Enrollment : 1211 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia (MA0901)
Study Start Date : April 2009
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Group 1 Drug: Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for treatment of menorrhagia

Group 2 Drug: Hormonal treatment
Hormonal treatment (including combined oral contraceptives or oral or injectable progestogens)

Group 3 Drug: Antifibrinolytic treatment
Antifibrinolytic treatment (such as tranexamic acid)

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

Secondary Outcome Measures :
  1. Bleeding pattern [ Time Frame: 12 months ]
  2. Patient satisfaction at end of documentation [ Time Frame: 12 months ]
  3. 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 ]
  4. Safety profile (adverse events) [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care

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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01085487

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Many Locations, Albania
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Many Locations, Colombia
Many Locations, Croatia
Czech Republic
Many Locations, Czech Republic
Many Locations, Jordan
Many Locations, Lebanon
Macedonia, The Former Yugoslav Republic of
Many Locations, Macedonia, The Former Yugoslav Republic of
Moldova, Republic of
Many Locations, Moldova, Republic of
Many Locations, Romania
South Africa
Many Locations, South Africa
Syrian Arab Republic
Many Locations, Syrian Arab Republic
Many Locations, Ukraine
Many Locations, Venezuela
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Healthcare Identifier: NCT01085487    
Other Study ID Numbers: 14536
MA0901 ( Other Identifier: company internal )
MA0701-14697 ( Other Identifier: company internal )
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Bayer:
Additional relevant MeSH terms:
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Uterine Hemorrhage
Uterine Diseases
Pathologic Processes
Menstruation Disturbances
Antifibrinolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action