check_circleStudy Completed
Menorrhagia
Bayer Identifier:
14697
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.
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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
647Trial Dates
November 2008 - November 2010Phase
N/ACould I Receive a placebo
NoProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, China | |
Completed | Many Locations, Indonesia | |
Completed | Many Locations, Taiwan | |
Completed | Many Locations, Malaysia | |
Completed | Many Locations, Pakistan | |
Completed | Many Locations, Korea, Republic Of | |
Completed | Many Locations, Hong Kong | |
Completed | Many Locations, Thailand |
Primary Outcome
- Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagiadate_rangeTime Frame:at 12 monthsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Bleeding patterndate_rangeTime Frame:at 12 monthsenhanced_encryptionnoSafety Issue:
- Patient satisfaction at end of documentationdate_rangeTime Frame:at 12 monthsenhanced_encryptionnoSafety Issue:
- Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)date_rangeTime Frame:at 12 monthsenhanced_encryptionnoSafety Issue:
- Adverse events collectiondate_rangeTime Frame:at 12 monthsenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A