Clinical trial NCT00868153: Mirena in Idiopathic Menorrhagia
Official title: Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Menorrhagia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-03-24
Enrollment: 1125
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
timeFrame: At vist 1 and 4
Secondary outcomes:
measure: Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study
timeFrame: Every visit
measure: The health-related quality of life questionnaire SF-36 at Visits 1 and 4
timeFrame: Visit 1 and 4
measure: The user satisfaction as recorded at Visit 4
timeFrame: visit 4
measure: Adverse reactions recorded in an ongoing way throughout the duration of the study
timeFrame: every visit
measure: Laboratory parameters as measured at Visits 1 and 4
timeFrame: visit 1 and 4
Other outcomes:
Locations:
city: Many Locations
country: Bulgaria
city: Many Locations
country: Croatia
city: Many Locations
country: India
city: Many Locations
country: Jordan
city: Many Locations
country: Kuwait
city: Many Locations
country: Pakistan
city: Many Locations
country: Romania
city: Many Locations
country: Russian Federation
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Serbia
city: Many Locations
country: Sri Lanka
city: Many Locations
country: Turkey
city: Many Locations
country: United Arab Emirates
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: