Menorrhagia, DysmenorrheaJ-MIRAINCT02475356
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
An observational study of Menorrhagia, Dysmenorrhea, run by Bayer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menorrhagia, Dysmenorrhea
- What is being tested?
- Levonorgestrel IUS (Mirena, BAY86-5028)
- How many people
- 601 participants
- Where
- 1 siteJapan
- Study dates
- 4 Aug 2015to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient whose purpose is only contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Menorrhagia, Dysmenorrhea
- Being tested
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Keywords
- Mirena, Heavy Menstrual Bleeding, Dysmenorrhea, Japan, Post-marketing surveillance
- Medical subject headings
- Menorrhagia, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUS (Mirena, BAY86-5028)Drug
The treatment of Mirena should comply with the local product information.
| Study group | Role | What they receive |
|---|---|---|
| Mirena | Mirena treatment group Receives: Drug: Levonorgestrel IUS (Mirena, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse drug reaction
Measured: Up to 12 months
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 12 months
Secondary outcomes (5)
Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months
Measured: Baseline and 12 months
Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months
Measured: 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
Measured: Baseline and 3 months, Baseline and 12 months
Change from baseline in dysmenorrhea pain using Visual Analogue scale
Measured: 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
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start4 Aug 2015
- Primary completion18 Jan 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menorrhagia, DysmenorrheaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475356
- Sponsor's protocol ID
- 18252
- Acronym
- J-MIRAI
- Status last verified
- Dec 2020
- First submitted
- 16 Jun 2015
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35705788
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
- ClinicalTrials.gov ID
- NCT02475356
- Acronym / sponsor ID
- J-MIRAI / 18252
- Conditions
- Menorrhagia, Dysmenorrhea
- Keywords
- Mirena, Heavy Menstrual Bleeding, Dysmenorrhea, Japan, Post-marketing surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2015 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirena | – | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)Mirena treatment group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient whose purpose is only contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel IUS (Mirena, BAY86-5028)The treatment of Mirena should comply with the local product information. | Drug | Mirena |
Primary outcome
Number of participants with adverse drug reaction
Time frame: Up to 12 months
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 12 months
5 secondary outcomes
Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months
Time frame: Baseline and 12 months
Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months
Time frame: Baseline and 12 months
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
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
Change from baseline in use of analgesics after Mirena insertion
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 35705788Momoeda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia, Dysmenorrhea, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse drug reaction (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.