Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea (J-MIRAI)
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|ClinicalTrials.gov Identifier: NCT02475356|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2015
Last Update Posted : June 20, 2019
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.
|Condition or disease||Intervention/treatment|
|Menorrhagia, Dysmenorrhea||Drug: Mirena (Levonorgestrel IUS, BAY86-5028)|
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.
|Study Type :||Observational|
|Actual Enrollment :||601 participants|
|Official Title:||Special Drug Use Investigation of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea|
|Actual Study Start Date :||August 4, 2015|
|Actual Primary Completion Date :||January 18, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Mirena treatment group
Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
The treatment of Mirena should comply with the local product information.
- Number of participants with adverse drug reaction [ Time Frame: Up to 12 monts ]
- Number of participants with adverse events [ Time Frame: Up to 12 monts ]
- Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months [ Time Frame: Baseline and 12 months ]
- Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months [ Time Frame: Baseline and 12 months ]
- Change from baseline in Quality of Life parameters assessed using MMAS or MDQ score after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months ]MMAS: Menorrhagia Multi Attribute Score for Heavy Menstrual Bleeding and MDQ: Menstrual Distress Questionnaire for dysmenorrhea
- Change from baseline in dysmenorrhea pain using Visual Analogue scale [ Time Frame: Baseline and 1 month,Baseline and 3 months,Baseline and 6 months,Baseline and 12 months ]
- Use of analgesic [ Time Frame: Baseline and 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT02475356
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|