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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 : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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)

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 601 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mirena
Mirena treatment group
Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
The treatment of Mirena should comply with the local product information.




Primary Outcome Measures :
  1. Number of participants with adverse drug reaction [ Time Frame: Up to 12 monts ]
  2. Number of participants with adverse events [ Time Frame: Up to 12 monts ]

Secondary Outcome Measures :
  1. Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months [ Time Frame: Baseline and 12 months ]
  2. Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months [ Time Frame: Baseline and 12 months ]
  3. 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

  4. 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 ]
  5. Use of analgesic [ Time Frame: Baseline and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients with Heavy menstrual bleeding (HMB) and/or dysmenorrhea in whom a decision to initiate treatment with Mirena has already been made will be enrolled in the study.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02475356     History of Changes
Other Study ID Numbers: 18252
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by Bayer:
Mirena
Heavy Menstrual Bleeding
Dysmenorrhea
Japan
Post-marketing surveillance
Additional relevant MeSH terms:
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Levonorgestrel
Menorrhagia
Hemorrhage
Dysmenorrhea
Pathologic Processes
Menstruation Disturbances
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral