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Completed

NCT Number: NCT02475356

Prospective, Non-interventional, Multi-center Safety Study 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.

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Key information

Conditions

Menorrhagia, Dysmenorrhea Dysmenorrhea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel IUS (Mirena, BAY86-5028)

Drug

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

Primary outcomes

  1. Number of participants with adverse drug reaction

    Time frame: Up to 12 months

  2. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 12 months

Secondary outcomes

  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. Change from baseline in use of analgesics after Mirena insertion

    Time frame: Baseline and 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: J-MIRAI

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2015
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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