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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00874653
First received: April 1, 2009
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for intrauterine treatment of menorrhagia

  Eligibility

Ages Eligible for Study:   30 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with a diagnosis of idiopathic menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator will be included in the study

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874653

Locations
Italy
Many Locations, Italy
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00874653     History of Changes
Other Study ID Numbers: 14175, MA0711IT
Study First Received: April 1, 2009
Last Updated: October 1, 2009
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
 Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 23, 2013