MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Bayer

Status

Completed

Conditions

Idiopathic Menorrhagia

Treatments

Drug: Hormonal treatment

Drug: Antifibrinolytic treatment

Drug: Levonorgestrel (Mirena, BAY86-5028)

Study type

Observational

Funder types

Industry

Identifiers

NCT01085487

MA0901 (Other Identifier)

14536

MA0701-14697 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,211 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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