Mirena in Idiopathic Menorrhagia

Study Overview
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Brief Summary
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This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.

Official Title
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Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia

Conditions
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Idiopathic Menorrhagia

Intervention / Treatment
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* Drug: Levonorgestrel IUS (Mirena , BAY86-5028)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ. Age limit 30-45 BMI= 18-34 Signed informed consent Exclusion Criteria: Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below: Known or suspected pregnancy; current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product. Nulliparity Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study. History of diabetes mellitus,cardiovascular disease and thyroid abnormalities Anticoagulation therapy Cancer history including breast cancer.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Levonorgestrel IUS (Mirena , BAY86-5028)<br>* One group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena |  | At vist 1 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study |  | Every visit | 
| The health-related quality of life questionnaire SF-36 at Visits 1 and 4 |  | Visit 1 and 4 | 
| The user satisfaction as recorded at Visit 4 |  | visit 4 | 
| Adverse reactions recorded in an ongoing way throughout the duration of the study |  | every visit | 
| Laboratory parameters as measured at Visits 1 and 4 |  | visit 1 and 4 |