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

Completed

• Conditions: Menorrhagia, Dysmenorrhea
• Interventions: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

• Registration Number: NCT02475356
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-18
• Study Start: 2015-08-04
• Primary Completion: 2019-01-18
• Study Completion: 2019-12-12
• Status Verified: 2020-12
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 601

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

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Exclusion Criteria

• Patient whose purpose is only contraception

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mirena	Levonorgestrel IUS (Mirena, BAY86-5028)	Mirena treatment group

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from baseline in use of analgesics after Mirena insertion	Baseline and 12 months
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 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 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