check_circleStudy Completed
Menorrhagia, Dysmenorrhea
Bayer Identifier:
18252
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Prospective, non-interventional, multi-center safety study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
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.
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.
Key Participants Requirements
Sex
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
601Trial Dates
August 2015 - December 2019Phase
Phase 4Could I Receive a placebo
NoProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Number of participants with adverse drug reactiondate_rangeTime Frame:Up to 12 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to 12 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 monthsdate_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 monthsdate_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- 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 dysmenorrheadate_rangeTime Frame:Baseline and 3 months, Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in dysmenorrhea pain using Visual Analogue scaledate_rangeTime Frame:Baseline and 1 month, Baseline and 3 months, Baseline and 6 months, Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in use of analgesics after Mirena insertiondate_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A