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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00874653
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Drug: Levonorgestrel (Mirena, BAY86-5028)

Study Design

• Study Type: Observational
• Actual Enrollment: 78 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
• Study Start Date: Apr 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36) [at 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Italy

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00874653
• Other Study ID Numbers: 14175; MA0711IT
• First Posted: Apr 2, 2009
• Last Update Posted: Jun 23, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Menorrhagia; Levonorgestrel

Study Results

No Results Posted as of Jun 23, 2014