Trial Condition(s):
Menorrhagia, Dysmenorrhea
Prospective, non-interventional, multi-center safety study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea (J-MIRAI)
Bayer Identifier:
18252
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Special Drug Use Investigation of Mirena for Heavy Menstrual Bleeding and dysmenorrhea
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with adverse drug reactionTimeframe: Up to 12 months
- Number of participants with treatment-emergent adverse events (TEAEs)Timeframe: Up to 12 months
Secondary Outcome
- Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 monthsTimeframe: Baseline and 12 months
- Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 monthsTimeframe: Baseline and 12 months
- Change from baseline in Quality of Life parameters assessed using MMAS or MDQ score after 3 and 12 monthsMMAS: Menorrhagia Multi Attribute Score for Heavy Menstrual Bleeding and MDQ: Menstrual Distress Questionnaire for dysmenorrheaTimeframe: Baseline and 3 months, Baseline and 12 months
- Change from baseline in dysmenorrhea pain using Visual Analogue scaleTimeframe: 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 insertionTimeframe: Baseline and 12 months
Additional Information
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