J-MIRAI: Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02475356

Collaborator

(none)

601

Enrollment

Location

52.3

Actual Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Menorrhagia, Dysmenorrhea	Drug: Levonorgestrel IUS (Mirena, 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.

Study Design

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 :

Aug 4, 2015

Actual Primary Completion Date :

Jan 18, 2019

Actual Study Completion Date :

Dec 12, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Mirena

Mirena treatment group

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

The treatment of Mirena should comply with the local product information.

Outcome Measures

Primary Outcome Measures

Number of participants with adverse drug reaction [Up to 12 months]
Number of participants with treatment-emergent adverse events (TEAEs) [Up to 12 months]

Secondary Outcome Measures

Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months [Baseline and 12 months]
Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months [Baseline and 12 months]
Change from baseline in Quality of Life parameters assessed using MMAS or MDQ score after 3 and 12 months [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 [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 insertion [Baseline and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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