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

NCT00874653 | Completed

• 2 other identifiers: 14175MA0711IT
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)

  at 12 months

Study Arms (1)

Group 1

Drug: Levonorgestrel (Mirena, BAY86-5028)

Interventions

Levonorgestrel (Mirena, BAY86-5028) DRUG

Women using Mirena for intrauterine treatment of menorrhagia

Group 1

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Italy

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

IT (1)