Mirena in Idiopathic Menorrhagia

February 16, 2015 updated by: Bayer

Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Levonorgestrel IUS (Mirena , BAY86-5028)
One group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
Time Frame: At vist 1 and 4
At vist 1 and 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study
Time Frame: Every visit
Every visit
The health-related quality of life questionnaire SF-36 at Visits 1 and 4
Time Frame: Visit 1 and 4
Visit 1 and 4
The user satisfaction as recorded at Visit 4
Time Frame: visit 4
visit 4
Adverse reactions recorded in an ongoing way throughout the duration of the study
Time Frame: every visit
every visit
Laboratory parameters as measured at Visits 1 and 4
Time Frame: visit 1 and 4
visit 1 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14494
  • MA0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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