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Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00874653
First received: April 1, 2009
Last updated: October 1, 2009
Last verified: October 2009
History of Changes

April 1, 2009
October 1, 2009
April 2008
January 2009   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00874653 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
Menorrhagia
Drug: Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for intrauterine treatment of menorrhagia
Group 1
Intervention: Drug: Levonorgestrel (Mirena, BAY86-5028)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Female
30 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00874653
14175, MA0711IT
No
Medical Director, Bayer Schering Pharma AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP