Idiopathic MenorrhagiaNCT00868153
Mirena in Idiopathic Menorrhagia
An observational study of Idiopathic Menorrhagia, run by Bayer at 13 sites in 13 countries.
Trial summary
This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Idiopathic Menorrhagia
- What is being tested?
- Levonorgestrel IUS (Mirena , BAY86-5028)
- How many people
- 1,125 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Aug 2004to Nov 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34
Who may be able to join
- Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
- Age limit 30-45
- BMI= 18-34
- Signed informed consent
Who cannot join
- Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
- Known or suspected pregnancy; 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
13 sites in 13 countries.
13 sites in 13 countries
About this study
Official title: Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia
This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.
- Conditions
- Idiopathic Menorrhagia
- Being tested
- Levonorgestrel IUS (Mirena , BAY86-5028)
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
One group
| 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.
To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
Measured: At vist 1 and 4
Secondary outcomes (5)
Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study
Measured: Every visit
The health-related quality of life questionnaire SF-36 at Visits 1 and 4
Measured: Visit 1 and 4
The user satisfaction as recorded at Visit 4
Measured: visit 4
Adverse reactions recorded in an ongoing way throughout the duration of the study
Measured: every visit
Laboratory parameters as measured at Visits 1 and 4
Measured: visit 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startAug 2004
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- 1,125 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
- NCT00868153
- Sponsor's protocol ID
- 14494
- Other IDs
- MA0501
- Status last verified
- Feb 2015
- First submitted
- 23 Mar 2009
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia
- ClinicalTrials.gov ID
- NCT00868153
- Acronym / sponsor ID
- 14494
- Conditions
- Idiopathic Menorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,125 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Mar 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.
This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel IUS (Mirena , BAY86-5028) |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34
Key inclusion criteria (4 listed)
- Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
- Age limit 30-45
- BMI= 18-34
- Signed informed consent
Key exclusion criteria (7 listed)
- Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
- Known or suspected pregnancy; 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
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)One group | Drug | Group 1 |
Primary outcome
To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
Time frame: At vist 1 and 4
5 secondary outcomes
Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study
Time frame: Every visit
The health-related quality of life questionnaire SF-36 at Visits 1 and 4
Time frame: Visit 1 and 4
The user satisfaction as recorded at Visit 4
Time frame: visit 4
Adverse reactions recorded in an ongoing way throughout the duration of the study
Time frame: every visit
Laboratory parameters as measured at Visits 1 and 4
Time frame: visit 1 and 4
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 18 Feb 2015.
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
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Menorrhagia, run by Bayer at 13 sites in 13 countries.
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 4 inclusion and 7 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 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Bulgaria, Croatia, India, Jordan, Kuwait and 8 more countries. 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?
To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena (time frame: At vist 1 and 4). 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 18 Feb 2015.