Trial Condition(s):
Menorrhagia
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
Bayer Identifier:
14175
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
78
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)Timeframe: at 12 months
Additional Information
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