ContraceptionNCT01414140
Mirena Post-marketing Surveillance in Japan
An observational study of Contraception, run by Bayer at 1 site in Japan.
Trial summary
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel IUS (Mirena, BAY86-5028)
- How many people
- 567 participants
- Where
- 1 siteJapan
- Study dates
- May 2007to Oct 2012
- 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: The target population of this study is women who patients who are inserted Mirena for intrauterine contraception. The study is expected to collect data of 550 women.
Who may be able to join
- Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
- Women who are contraindicated based on the product label
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Mirena
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.
- Conditions
- Contraception
- Being tested
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Keywords
- Mirena, contraception
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
Women inserted Mirena for intrauterine contraception.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Levonorgestrel IUS (Mirena, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena
Measured: After Mirera insertion, up to 5 years
Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena
Measured: After Mirera insertion, up to 5 years
Secondary outcomes (3)
Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena
Measured: After Mirera insertion, up to 5 years
Pregnancy rate
Measured: After Mirera insertion, up to 5 years
Released amount of Levonorgestrel [estimated from removed Mirena]
Measured: After Mirera insertion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMay 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 567 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
- NCT01414140
- Sponsor's protocol ID
- 15036
- Other IDs
- MIRENA
- Status last verified
- Jan 2014
- First submitted
- 10 Aug 2011
- Last updated
- 9 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Mirena
- ClinicalTrials.gov ID
- NCT01414140
- Acronym / sponsor ID
- 15036
- Conditions
- Contraception
- Keywords
- Mirena, contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Aug 2011 (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.
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel IUS (Mirena, BAY86-5028) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population of this study is women who patients who are inserted Mirena for intrauterine contraception. The study is expected to collect data of 550 women.
Key inclusion criteria (2 listed)
- Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
- Women who are contraindicated based on the product label
Key exclusion criteria (0 listed)
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)Women inserted Mirena for intrauterine contraception. | Drug | Group 1 |
Primary outcome
Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena
Time frame: After Mirera insertion, up to 5 years
Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena
Time frame: After Mirera insertion, up to 5 years
3 secondary outcomes
Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena
Time frame: After Mirera insertion, up to 5 years
Pregnancy rate
Time frame: After Mirera insertion, up to 5 years
Released amount of Levonorgestrel [estimated from removed Mirena]
Time frame: After Mirera insertion, up to 5 years
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 9 Jan 2014.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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 Contraception, 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 2 inclusion and 0 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 9 Jan 2014. 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?
Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena (time frame: After Mirera insertion, up to 5 years). 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?
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 9 Jan 2014.