Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1125 participants
OBSERVATIONAL
2004-08-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Levonorgestrel IUS (Mirena , BAY86-5028)
One group
Interventions
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Levonorgestrel IUS (Mirena , BAY86-5028)
One group
Eligibility Criteria
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Inclusion Criteria
* Age limit 30-45
* BMI= 18-34
* Signed informed consent
Exclusion Criteria
* 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.
30 Years
45 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Many Locations, , Bulgaria
Many Locations, , Croatia
Many Locations, , India
Many Locations, , Jordan
Many Locations, , Kuwait
Many Locations, , Pakistan
Many Locations, , Romania
Many Locations, , Russia
Many Locations, , Saudi Arabia
Many Locations, , Serbia
Many Locations, , Sri Lanka
Many Locations, , Turkey (Türkiye)
Many Locations, , United Arab Emirates
Countries
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Other Identifiers
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MA0501
Identifier Type: -
Identifier Source: secondary_id
14494
Identifier Type: -
Identifier Source: org_study_id
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