Clinical trial NCT01085487: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia
Official title: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia (MA0901)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Menorrhagia
Keywords: Menorrhagia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 1211
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care

Brief summary: The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.

Detailed description: The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).

Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697 (NCT00864136), 14536.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18-45 (inclusive) not intending to become pregnant during the next year
* Women complaining of heavy menstrual bleeding over several consecutive cycles
* Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
* Informed consent (where required by laws or regulations)

Exclusion Criteria:

* The contraindications and warnings of the respective Summary of Product Characteristics (Mirena®, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
* Women taking hormone replacement therapy
* Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
* Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
* Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia

Primary outcomes:
measure: Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia
timeFrame: 12 months
Secondary outcomes:
measure: Bleeding pattern
timeFrame: 12 months
measure: Patient satisfaction at end of documentation
timeFrame: 12 months
measure: Impact of the therapy in terms of patient-reported health outcomes assessed using a validated questionnaire (Shaw RW et. al., British Journal of Obstetrics and Gynaecology, Vol 105(11), 1998.)
timeFrame: 12 months
measure: Safety profile (adverse events)
timeFrame: 12 months
Other outcomes:
Locations:
city: Many Locations
country: Albania
city: Many Locations
country: Bosnia and Herzegovina
city: Many Locations
country: Colombia
city: Many Locations
country: Croatia
city: Many Locations
country: Czech Republic
city: Many Locations
country: Jordan
city: Many Locations
country: Lebanon
city: Many Locations
country: Macedonia, The Former Yugoslav Republic of
city: Many Locations
country: Moldova, Republic of
city: Many Locations
country: Romania
city: Many Locations
country: South Africa
city: Many Locations
country: Syrian Arab Republic
city: Many Locations
country: Ukraine
city: Many Locations
country: Venezuela
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: