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

NCT ID: NCT00874653

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-12-31

Brief 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.

Conditions

Menorrhagia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Levonorgestrel (Mirena, BAY86-5028)

Intervention Type: DRUG

Women using Mirena for intrauterine treatment of menorrhagia

Interventions

Levonorgestrel (Mirena, BAY86-5028)

Women using Mirena for intrauterine treatment of menorrhagia

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , Italy

Countries

Italy

Other Identifiers

MA0711IT

Identifier Type: OTHER

Identifier Source: secondary_id

14175

Identifier Type: -

Identifier Source: org_study_id