Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding

Completed

• Conditions: Menorrhagia
• Interventions: Drug: Levonorgestrel (Mirena, BAY86-5028)

• Registration Number: NCT00874653
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-04
• Study Completion: 2008-12
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel (Mirena, BAY86-5028)	-

Primary Outcome Measures

Name	Time	Method
The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)	at 12 months