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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

601 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-04

Study Completion Date

2019-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mirena or Conventional Medical Treatment for Menorrhagia

NCT00864136

Menorrhagia

COMPLETED

Mirena in Idiopathic Menorrhagia

NCT00868153

Idiopathic Menorrhagia

COMPLETED

Mirena Post-marketing Surveillance in Japan

NCT01414140

Contraception

COMPLETED

Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

NCT00393198

Contraception Menorrhagia

COMPLETED PHASE4

Mirena Extension Trial

NCT02985541

Contraception

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menorrhagia, Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mirena

Mirena treatment group

Levonorgestrel IUS (Mirena, BAY86-5028)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levonorgestrel IUS (Mirena, BAY86-5028)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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