Status:
COMPLETED
Mirena in Idiopathic Menorrhagia
Lead Sponsor:
Bayer
Conditions:
Idiopathic Menorrhagia
Eligibility:
FEMALE
30-45 years
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
1125 Patients enrolled
Trial Details
Trial ID
NCT00868153
Start Date
August 1 2004
End Date
November 1 2008
Last Update
February 18 2015
Active Locations (13)
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1
Many Locations, Bulgaria
2
Many Locations, Croatia
3
Many Locations, India
4
Many Locations, Jordan