Idiopathic Menorrhagia
Conditions
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.
Interventions
DRUGLevonorgestrel IUS (Mirena , BAY86-5028)
One group
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ. * Age limit 30-45 * BMI= 18-34 * Signed informed consent
Exclusion criteria
* Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below: * Known or suspected pregnancy; 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 |
|---|---|
| To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena | At vist 1 and 4 |
Secondary
| Measure | Time frame |
|---|---|
| Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study | Every visit |
| The health-related quality of life questionnaire SF-36 at Visits 1 and 4 | Visit 1 and 4 |
| The user satisfaction as recorded at Visit 4 | visit 4 |
| Adverse reactions recorded in an ongoing way throughout the duration of the study | every visit |
| Laboratory parameters as measured at Visits 1 and 4 | visit 1 and 4 |
Countries
Bulgaria, Croatia, India, Jordan, Kuwait, Pakistan, Romania, Russia, Saudi Arabia, Serbia, Sri Lanka, Turkey (Türkiye), United Arab Emirates
Outcome results
None listed