Menorrhagia
Conditions
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.
Interventions
Women using Mirena for intrauterine treatment of menorrhagia
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36) | at 12 months |
Countries
Italy
Outcome results
None listed