Clinical Trial: Mirena in Idiopathic Menorrhagia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia
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 patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena [ Time Frame: At vist 1 and 4 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study [ Time Frame: Every visit ]
- The health-related quality of life questionnaire SF-36 at Visits 1 and 4 [ Time Frame: Visit 1 and 4 ]
- The user satisfaction as recorded at Visit 4 [ Time Frame: visit 4 ]
- Adverse reactions recorded in an ongoing way throughout the duration of the study [ Time Frame: every visit ]
- Laboratory parameters as measured at Visits 1 and 4 [ Time Frame: visit 1 and 4 ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: March 23, 2009
Date Started: August 2004
Date Completion:
Last Updated: February 16, 2015
Last Verified: February 2015
