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Mirena in Idiopathic Menorrhagia

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

Condition(s) targeted: Idiopathic Menorrhagia

Intervention: Levonorgestrel IUS (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

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.

Clinical Details

Official title: Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia

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

Primary outcome: To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena

Secondary outcome:

Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study

The health-related quality of life questionnaire SF-36 at Visits 1 and 4

The user satisfaction as recorded at Visit 4

Adverse reactions recorded in an ongoing way throughout the duration of the study

Laboratory parameters as measured at Visits 1 and 4

Eligibility

Minimum age: 30 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Many Locations, Bulgaria

Many Locations, Croatia

Many Locations, India

Many Locations, Jordan

Many Locations, Kuwait

Many Locations, Pakistan

Many Locations, Romania

Many Locations, Russian Federation

Many Locations, Saudi Arabia

Many Locations, Serbia

Many Locations, Sri Lanka

Many Locations, Turkey

Many Locations, United Arab Emirates

Additional Information

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

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: August 2004
Last updated: February 16, 2015

Page last updated: August 23, 2015

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