Medicated Intrauterine DevicesPhase 4NCT00696202
Mirena Efficiency and Tolerability During the First Year of Use
A Phase 4 study testing Mirena (BAY86-5028) in people with Medicated Intrauterine Devices and Contraception, run by Bayer at 1 site in France.
Trial summary
In this trial the efficacy and safety of Mirena was investigated during the first year of use Read more about this study
- Who is it for?
- Ages 25 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medicated Intrauterine Devices, Contraception
- What is being tested?
- Mirena (BAY86-5028)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2003to Mar 2005
- Phase
- Phase 4
- 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 25 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).
Who cannot join
- Standard exclusion criteria for use of intrauterine hormone devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum
In this trial the efficacy and safety of Mirena was investigated during the first year of use
- Conditions
- Medicated Intrauterine Devices, Contraception
- Being tested
- Mirena (BAY86-5028)
- Keywords
- Mirena, Levonorgestrel, Intrauterine device, Efficacy, Tolerability, First year of use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirena (BAY86-5028)Drug
Intrauterine levonorgestrel containing device (market product)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Mirena (BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena
Measured: within 12 months after randomization
Secondary outcomes (1)
General safety assessment
Measured: within 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startSep 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medicated Intrauterine DevicesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 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
- NCT00696202
- Sponsor's protocol ID
- 91295
- Other IDs
- 307702
- Status last verified
- Dec 2014
- First submitted
- 10 Jun 2008
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum
- ClinicalTrials.gov ID
- NCT00696202
- Acronym / sponsor ID
- 91295
- Conditions
- Medicated Intrauterine Devices, Contraception
- Keywords
- Mirena, Levonorgestrel, Intrauterine device, Efficacy, Tolerability, First year of use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 12 Jun 2008 (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.
In this trial the efficacy and safety of Mirena was investigated during the first year of use
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Mirena (BAY86-5028) |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).
Key exclusion criteria (1 listed)
- Standard exclusion criteria for use of intrauterine hormone devices
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 |
|---|---|---|
| Mirena (BAY86-5028)Intrauterine levonorgestrel containing device (market product) | Drug | Arm 1 |
Primary outcome
Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena
Time frame: within 12 months after randomization
1 secondary outcome
General safety assessment
Time frame: within 12 months after randomization
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 31 Dec 2014.
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Eumenorrhea, Intrauterine Devices, Medicated
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?
A Phase 4 study testing Mirena (BAY86-5028) in people with Medicated Intrauterine Devices and Contraception, run by Bayer at 1 site in France.
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 1 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 31 Dec 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena (time frame: within 12 months after randomization). 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 31 Dec 2014.