Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

Study Overview
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Brief Summary
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The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the first 12 months Mirena insertion. The secondary objective(s) in this study is/are collecting information on Mirena effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and dysmenorrhea pain as far as these are recorded under routine clinical practice.

Detailed Description
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This local, non-interventional, multicenter, single-cohort study using primary data includes patients treated with Mirena for Heavy menstrual bleeding(HMB) and/or dysmenorrhea (contraception is not included). A total of 600 patients (valid for safety analysis) is planned to be enrolled in two years. No formal sample size estimation was conducted, it was determined based on feasibility. Target population is patients with HMB and/or dysmenorrhea diagnosis. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Mirena treatment.

Official Title
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Special Drug Use Investigation of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

Conditions
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Menorrhagia, Dysmenorrhea

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: Female patients diagnosed with HMB or/and dysmenorrhea. Patients for whom newly starting treatment with Mirena was made as per investigator's routine treatment practice Written informed consent Exclusion Criteria: Patient whose purpose is only contraception
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 |
| --- | --- |
| Mirena<br>Mirena treatment group | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)<br>* The treatment of Mirena should comply with the local product information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse drug reaction |  | Up to 12 months | 
| Number of participants with treatment-emergent adverse events (TEAEs) |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months |  | Baseline and 12 months | 
| Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months |  | Baseline and 12 months | 
| Change from baseline in Quality of Life parameters assessed using MMAS or MDQ score after 3 and 12 months | MMAS: Menorrhagia Multi Attribute Score for Heavy Menstrual Bleeding and MDQ: Menstrual Distress Questionnaire for dysmenorrhea | Baseline and 3 months, Baseline and 12 months | 
| Change from baseline in dysmenorrhea pain using Visual Analogue scale |  | Baseline and 1 month, Baseline and 3 months, Baseline and 6 months, Baseline and 12 months | 
| Change from baseline in use of analgesics after Mirena insertion |  | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirena, Heavy Menstrual Bleeding, Dysmenorrhea, Japan, Post-marketing surveillance