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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menorrhagia

Intervention: Levonorgestrel (Mirena, BAY86-5028) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)

Eligibility

Minimum age: 30 Years. Maximum age: 49 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Many Locations, Italy
Additional Information

Click here and search for drug information provided by the FDA.

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Click here to find results for studies related to Bayer Healthcare products.

Starting date: April 2008
Last updated: June 20, 2014

Page last updated: August 23, 2015

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