check_circleStudy Completed
Idiopathic Menorrhagia
Bayer Identifier:
14536
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
MiCo - Mirena or conventional medical treatment for menorrhagia
Trial purpose
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.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.
Key Participants Requirements
Sex
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
1211Trial Dates
April 2009 - June 2011Phase
N/ACould I Receive a placebo
NoProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Colombia | |
Completed | Many Locations, Croatia | |
Completed | Many Locations, Moldova | |
Completed | Many Locations, Albania | |
Completed | Many Locations, Lebanon | |
Completed | Many Locations, South Africa | |
Completed | Many Locations, Czech Republic | |
Completed | Many Locations, Ukraine | |
Completed | Many Locations, Venezuela | |
Terminated | Many Locations, Romania | |
Completed | Many Locations, Macedonia | |
Completed | Many Locations, Jordan | |
Completed | Many Locations, Syria | |
Completed | Many Locations, Bosnia And Herzegovina |
Primary Outcome
- Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagiadate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Bleeding patterndate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Patient satisfaction at end of documentationdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Impact of the therapy in terms of patient-reported health outcomes assessed using a validated questionnaire (Shaw RW et. al., British Journal of Obstetrics and Gynaecology, Vol 105(11), 1998.)date_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Safety profile (adverse events)date_rangeTime Frame:12 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A