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

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

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.

Study Overview

• Status: Completed
• Conditions: Menorrhagia, Dysmenorrhea
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 601

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	MMAS: Menorrhagia Multi Attribute Score for Heavy Menstrual Bleeding and MDQ: Menstrual Distress Questionnaire for dysmenorrhea	Baseline and 3 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 use of analgesics after Mirena insertion		Baseline and 12 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Momoeda M, Akira S, Harada T, Kitawaki J, Maeda N, Ota I, Yoshihara K, Takahashi N. Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting. Adv Ther. 2022 Aug;39(8):3616-3634. doi: 10.1007/s12325-022-02205-2. Epub 2022 Jun 16.

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 4, 2015
• Primary Completion (ACTUAL): January 18, 2019
• Study Completion (ACTUAL): December 12, 2019

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (ESTIMATE): June 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Japan; Post-marketing surveillance; Heavy Menstrual Bleeding; Mirena
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Menstruation Disturbances; Pelvic Pain; Uterine Hemorrhage; Hemorrhage; Dysmenorrhea; Menorrhagia; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 18252

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No