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

Menorrhagia, Dysmenorrhea Clinical Trial

— J-MIRAI  

Official title:

Special Drug Use Investigation of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475356
• Other study ID #: 18252
• Status: Completed
• Start date: August 4, 2015
• Est. completion date: December 12, 2019

Study information

• Verified date: December 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: December 12, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Hemorrhage
• Menorrhagia
• Menorrhagia, Dysmenorrhea

Intervention

Drug:
• Levonorgestrel IUS (Mirena, BAY86-5028)
The treatment of Mirena should comply with the local product information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse drug reaction		Up to 12 months
Primary	Number of participants with treatment-emergent adverse events (TEAEs)		Up to 12 months
Secondary	Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months		Baseline and 12 months
Secondary	Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months		Baseline and 12 months
Secondary	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	Baseline and 3 months, Baseline and 12 months
Secondary	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
Secondary	Change from baseline in use of analgesics after Mirena insertion		Baseline and 12 months

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