check_circleStudy Completed

Menorrhagia

Bayer Identifier:

14175

ClinicalTrials.gov Identifier:

NCT00874653

EudraCT Number:

Not Available

EU CT Number:

Not Available
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding

Trial 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.

Key Participants Requirements

Sex

Female

Age

30 - 49 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
78
Trial Dates
April 2008 - December 2008
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Italy

Primary Outcome

  • The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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