MenorrhagiaNCT00874653
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
An observational study of Menorrhagia, run by Bayer at 1 site in Italy.
Trial summary
The purposes of this study are: To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena. To collect italian data for Mirena in clinical routine. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Levonorgestrel (Mirena, BAY86-5028)
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2008to Dec 2008
- 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 30 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with a diagnosis of idiopathic menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator will be included in the study
Who may be able to join
- Women diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. These women should also accept to be on contraception during the time period that they have Mirena in situ
- Body Mass Index = 18-30
Who cannot join
- One or more of the following disorders: Current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product
- Nulliparity
- Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
- History of diabetes mellitus, cardiovascular disease and thyroid abnormalities
- Anticoagulation therapy
- Cancer history including breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
The purposes of this study are:
- To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena.
- To collect italian data for Mirena in clinical routine.
- Conditions
- Menorrhagia
- Being tested
- Levonorgestrel (Mirena, BAY86-5028)
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (Mirena, BAY86-5028)Drug
Women using Mirena for intrauterine treatment of menorrhagia
| 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.
The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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
- 78 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
- NCT00874653
- Sponsor's protocol ID
- 14175
- Other IDs
- MA0711IT
- Status last verified
- Jun 2014
- First submitted
- 1 Apr 2009
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
- ClinicalTrials.gov ID
- NCT00874653
- Acronym / sponsor ID
- 14175
- Conditions
- Menorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Study completion
- Dec 2008 (actual)
- First posted
- 2 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.
The purposes of this study are:
- To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena.
- To collect italian data for Mirena in clinical routine.
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
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with a diagnosis of idiopathic menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator will be included in the study
Key inclusion criteria (2 listed)
- Women diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. These women should also accept to be on contraception during the time period that they have Mirena in situ
- Body Mass Index = 18-30
Key exclusion criteria (6 listed)
- One or more of the following disorders: Current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product
- Nulliparity
- Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
- History of diabetes mellitus, cardiovascular disease and thyroid abnormalities
- Anticoagulation therapy
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)Women using Mirena for intrauterine treatment of menorrhagia | Drug | Group 1 |
Primary outcome
The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)
Time frame: at 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 23 Jun 2014.
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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, run by Bayer at 1 site in Italy.
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 6 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 23 Jun 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 Italy. 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?
The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36) (time frame: at 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 23 Jun 2014.