Study Completed

Menorrhagia

Bayer Identifier:

14175

ClinicalTrials.gov Identifier:

NCT00874653

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Female

Age

30 - 49 Years

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

Trial Dates

April 2008 - December 2008

Phase

N/A

Could I Receive a placebo

Products

Mirena (Levonorgestrel IUS, BAY86-5028)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Italy

Primary Outcome

The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)
Time Frame:
at 12 months
Safety Issue:
No

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

N/A

Additional Information

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