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Completed

NCT Number: NCT01085487

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

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.

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Key information

Conditions

Idiopathic Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Albania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel (Mirena, BAY86-5028)

Drug

Women using Mirena for treatment of menorrhagia

hormonal treatment

Drug

Hormonal treatment (including combined oral contraceptives or oral or injectable progestogens)

Antifibrinolytic treatment

Drug

Antifibrinolytic treatment (such as tranexamic acid)

Primary outcomes

  1. Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia

    Time frame: 12 months

Secondary outcomes

  1. Bleeding pattern

    Time frame: 12 months

  2. Patient satisfaction at end of documentation

    Time frame: 12 months

  3. 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.)

    Time frame: 12 months

  4. Safety profile (adverse events)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia (MA0901)

Important dates

Study start
2009
Study completion
2011
First posted
Mar 12, 2010
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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