check_circleStudy Completed

Idiopathic Menorrhagia

Bayer Identifier:

14494

ClinicalTrials.gov Identifier:

NCT00868153

EudraCT Number:

Not Available

EU CT Number:

Not Available
Mirena in idiopathic Menorrhagia

Trial purpose

This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.

Key Participants Requirements

Sex

Female

Age

30 - 45 Years
  • - Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
    - Age limit 30-45
    - BMI= 18-34
    - Signed informed consent
  • - Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
    - Known or suspected pregnancy; 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
1125
Trial Dates
August 2004 - November 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, Bulgaria
Completed
Many Locations, Croatia
Completed
Many Locations, Pakistan
Completed
Many Locations, Romania
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Jordan
Completed
Many Locations, United Arab Emirates
Completed
Many Locations, Turkey
Completed
Many Locations, Russia
Completed
Many Locations, India
Completed
Many Locations, Serbia
Completed
Many Locations, Sri Lanka
Completed
Many Locations, Kuwait

Primary Outcome

  • To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
    date_rangeTime Frame:
    At vist 1 and 4
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study
    date_rangeTime Frame:
    Every visit
    enhanced_encryption
    Safety Issue:
    no
  • The health-related quality of life questionnaire SF-36 at Visits 1 and 4
    date_rangeTime Frame:
    Visit 1 and 4
    enhanced_encryption
    Safety Issue:
    no
  • The user satisfaction as recorded at Visit 4
    date_rangeTime Frame:
    visit 4
    enhanced_encryption
    Safety Issue:
    no
  • Adverse reactions recorded in an ongoing way throughout the duration of the study
    date_rangeTime Frame:
    every visit
    enhanced_encryption
    Safety Issue:
    yes
  • Laboratory parameters as measured at Visits 1 and 4
    date_rangeTime Frame:
    visit 1 and 4
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Levonorgestrel Releasing Intrauterine Device (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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