Mirena or Conventional Medical Treatment for Menorrhagia
NCT ID: NCT00864136
Last Updated: 2015-07-01
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
647 participants
OBSERVATIONAL
2008-11-30
2010-11-30
Brief Summary
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It is planned to conduct the study in about 10 countries with a total of 1000 patients. In several countries, a comparator group will also be documented.
For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.
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Detailed Description
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Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697, 14536 (NCT01085487).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for treatment of menorrhagia
Group 2
Conventional medical treatment
Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug
Group 3
Conventional medical treatment
Women using anti-fibrinolytic agent for treatment of menorrhagia
Interventions
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Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for treatment of menorrhagia
Conventional medical treatment
Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug
Conventional medical treatment
Women using anti-fibrinolytic agent for treatment of menorrhagia
Eligibility Criteria
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Inclusion Criteria
* Women complaining of heavy menstrual bleeding over several consecutive cycles
* Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
* Informed consent (where required by laws or regulations)
Exclusion Criteria
* Women taking hormone replacement therapy
* Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
* Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
* Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia
18 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, , China
Many Locations, , Hong Kong
Many Locations, , Indonesia
Many Locations, , Malaysia
Many Locations, , Pakistan
Many Locations, , South Korea
Many Locations, , Taiwan
Many Locations, , Thailand
Countries
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References
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Lee BS, Ling X, Asif S, Kraemer P, Hanisch JU, Inki P. Levonorgestrel-releasing intrauterine system versus conventional medical therapy for heavy menstrual bleeding in the Asia-Pacific region. Int J Gynaecol Obstet. 2013 Apr;121(1):24-30. doi: 10.1016/j.ijgo.2012.10.028. Epub 2013 Jan 20.
Other Identifiers
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MA0701
Identifier Type: OTHER
Identifier Source: secondary_id
MA0901 - non-East Asia
Identifier Type: OTHER
Identifier Source: secondary_id
14697
Identifier Type: -
Identifier Source: org_study_id
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