NCT02475356 (J-MIRAI) is a clinical trial of Levonorgestrel IUS (Mirena, BAY86-5028) in Menorrhagia, Dysmenorrhea, sponsored by Bayer.

Who is sponsoring NCT02475356?

NCT02475356 is sponsored by Bayer.

What drugs are being tested in NCT02475356?

Interventions in NCT02475356: Levonorgestrel IUS (Mirena, BAY86-5028).

What condition does NCT02475356 study?

NCT02475356 studies Menorrhagia, Dysmenorrhea.

Is NCT02475356 still recruiting?

NCT02475356 is currently completed. Last updated 28 January 2021.

Last reviewed 2021-01-28 · How we verify

NCT02475356: J-MIRAI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 28 January 2021

What this trial tests

trial testing Levonorgestrel IUS (Mirena, BAY86-5028) in Menorrhagia, Dysmenorrhea in 601 participants. Completed in 12 December 2019.

Timeline

4 August 2015

Primary endpoint
18 January 2019

12 December 2019

Quick facts

Lead sponsor	Bayer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	601
Start date	4 August 2015
Primary completion	18 January 2019
Estimated completion	12 December 2019
Sites	1 location across Japan

Drugs / interventions tested

Levonorgestrel IUS (Mirena, BAY86-5028) — full drug profile →

Conditions studied

Menorrhagia, Dysmenorrhea — all drugs for Menorrhagia, Dysmenorrhea →

Sponsor

Bayer — full company profile →

Who can join

Eligibility, female only, with Menorrhagia, Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting.
Momoeda M, Akira S, Harada T, Kitawaki J, et al · · 2022 · cited 3× · PMID 35705788 · DOI 10.1007/s12325-022-02205-2
Quality of life of Japanese women with dysmenorrhea and/or heavy menstrual bleeding treated with levonorgestrel intrauterine delivery system in a real-world setting
Momoeda M, Akira S, Harada T, Kitawaki J, et al · · 2022 · DOI 10.21203/rs.3.rs-842152/v1

Verify or expand the search:

Other trials of Levonorgestrel IUS (Mirena, BAY86-5028)

Trials testing the same drug.

NCT02985541 — Mirena Extension Trial · Phase 3 · completed

Other recruiting trials for Menorrhagia, Dysmenorrhea

Currently open trials in the same condition.

NCT07478614 — Multicenter Observational Cohort Study on the Epidemiology of Therapeutic Strategies in Patients Affected by Adenomyosis · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02475356 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 28 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02475356.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing