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

Menorrhagia Clinical Trial

Official title:

Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874653
• Other study ID #: 14175
• Secondary ID: MA0711IT
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: June 20, 2014
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Drug:
• Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for intrauterine treatment of menorrhagia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)		at 12 months	No

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