check_circleStudy Completed

Menorrhagia, Dysmenorrhea

Bayer Identifier:

18252

ClinicalTrials.gov Identifier:

NCT02475356

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - 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


  • - Patient whose purpose is only contraception

Trial summary

Enrollment Goal
601
Trial Dates
August 2015 - December 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Number of participants with adverse drug reaction
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Baseline and 3 months, Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in dysmenorrhea pain using Visual Analogue scale
    date_rangeTime Frame:
    Baseline and 1 month, Baseline and 3 months, Baseline and 6 months, Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in use of analgesics after Mirena insertion
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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