Trial Condition(s):
Menorrhagia
Mirena or conventional medical treatment for menorrhagia
Bayer Identifier:
14697
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.
It is planned to conduct the study in about 10 countries with a total of 1000 patients. In several countries, a comparator group will also be documented.
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.
Inclusion Criteria
- Women between the ages of 18-45 (inclusive) not intending to get 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Indonesia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Malaysia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Pakistan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Thailand | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
MiCo - Mirena or conventional medical treatment for menorrhagia
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagiaTimeframe: at 12 months
Secondary Outcome
- Bleeding patternTimeframe: at 12 months
- Patient satisfaction at end of documentationTimeframe: at 12 months
- Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)Timeframe: at 12 months
- Adverse events collectionTimeframe: at 12 months
Additional Information
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