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

Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia

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.

Study Overview

• Status: Completed
• Conditions: Menorrhagia
• Intervention / Treatment: Drug: Levonorgestrel (Mirena, BAY86-5028)

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Italy
  • Many Locations, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Levonorgestrel (Mirena, BAY86-5028); Women using Mirena for intrauterine treatment of menorrhagia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)	at 12 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: April 1, 2009
• First Submitted That Met QC Criteria: April 1, 2009
• First Posted (ESTIMATE): April 2, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 14175; MA0711IT (OTHER: Other company ID)