ContraceptionNCT00883662
Mirena Observational Program
An observational study of Contraception and Menorrhagia, run by Bayer at 1 site in Kazakhstan.
Trial summary
Mirena is used for long-term in Kazakhstan, and in our observational program we would like to study patients distribution per indications of Mirena, and also patient compliance within a year after Mirena insertion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception, Menorrhagia, Endometrial Hyperplasia
- What is being tested?
- Levonorgestrel (Mirena, BAY86-5028)
- How many people
- 2,725 participants
- Where
- 1 siteKazakhstan
- Study dates
- May 2009to Nov 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
Who may be able to join
- Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
Who cannot join
- All patients with contraindications to Mirena insertion, according to approved prescribing information.
Trial locations and contacts
1 site in 1 country.
About this study
Mirena is used for long-term in Kazakhstan, and in our observational program we would like to study patients distribution per indications of Mirena, and also patient compliance within a year after Mirena insertion. For patients with all approved indications for Mirena use: contraception, treatment of menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy
- Being tested
- Levonorgestrel (Mirena, BAY86-5028)
- Medical subject headings
- Menorrhagia, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (Mirena, BAY86-5028)Drug
Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Levonorgestrel (Mirena, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient distribution per indication
Measured: 12 months
Secondary outcomes (1)
Patient compliance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2014
- Study completionNov 2015
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,725 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
- NCT00883662
- Sponsor's protocol ID
- 14474
- Other IDs
- MA0910KZ
- Status last verified
- Sep 2016
- First submitted
- 16 Apr 2009
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirena Observational Program
- ClinicalTrials.gov ID
- NCT00883662
- Acronym / sponsor ID
- 14474
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,725 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Apr 2009 (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.
Mirena is used for long-term in Kazakhstan, and in our observational program we would like to study patients distribution per indications of Mirena, and also patient compliance within a year after Mirena insertion. For patients with all approved indications for Mirena use: contraception, treatment of menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel (Mirena, BAY86-5028) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
Key inclusion criteria (1 listed)
- Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
Key exclusion criteria (1 listed)
- All patients with contraindications to Mirena insertion, according to approved prescribing information.
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 (Mirena, BAY86-5028)Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications | Drug | Group 1 |
Primary outcome
Patient distribution per indication
Time frame: 12 months
1 secondary outcome
Patient compliance
Time frame: 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 30 Sep 2016.
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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 Contraception and Menorrhagia, run by Bayer at 1 site in Kazakhstan.
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 30 Sep 2016. 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 Kazakhstan. 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?
Patient distribution per indication (time frame: 12 months). 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 30 Sep 2016.