Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874653
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date April 1, 2009
First Posted Date April 2, 2009
Last Update Posted Date June 23, 2014
Study Start Date April 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: April 1, 2009)
The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36) [ Time Frame: at 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
Official Title Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
Brief Summary

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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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
Condition Menorrhagia
Intervention Drug: Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for intrauterine treatment of menorrhagia
Study Groups/Cohorts Group 1
Intervention: Drug: Levonorgestrel (Mirena, BAY86-5028)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2013)
78
Original Estimated Enrollment
 (submitted: April 1, 2009)
100
Actual Study Completion Date December 2008
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 49 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00874653
Other Study ID Numbers 14175
MA0711IT ( Other Identifier: Other company ID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2014