check_circleStudy Completed

Menorrhagia

Bayer Identifier:

14697

ClinicalTrials.gov Identifier:

NCT00864136

EudraCT Number:

Not Available

EU CT Number:

Not Available
Mirena or conventional medical treatment for menorrhagia

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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)
  • - 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
647
Trial Dates
November 2008 - November 2010
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, China
Completed
Many Locations, Indonesia
Completed
Many Locations, Taiwan
Completed
Many Locations, Malaysia
Completed
Many Locations, Pakistan
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Hong Kong
Completed
Many Locations, Thailand

Primary Outcome

  • Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Bleeding pattern
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    no
  • Patient satisfaction at end of documentation
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    no
  • Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    no
  • Adverse events collection
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    yes

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
N/A

Additional Information

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