MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

NCT ID: NCT01085487

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1211 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Idiopathic Menorrhagia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Levonorgestrel (Mirena, BAY86-5028)

Intervention Type: DRUG

Women using Mirena for treatment of menorrhagia

Group 2

Hormonal treatment

Intervention Type: DRUG

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

Group 3

Antifibrinolytic treatment

Intervention Type: DRUG

Antifibrinolytic treatment (such as tranexamic acid)

Interventions

Levonorgestrel (Mirena, BAY86-5028)

Women using Mirena for treatment of menorrhagia

Intervention Type: DRUG

Hormonal treatment

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

Intervention Type: DRUG

Antifibrinolytic treatment

Antifibrinolytic treatment (such as tranexamic acid)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , Albania

Many Locations, , Bosnia and Herzegovina

Many Locations, , Colombia

Many Locations, , Croatia

Many Locations, , Czechia

Many Locations, , Jordan

Many Locations, , Lebanon

Many Locations, , Moldova

Many Locations, , North Macedonia

Many Locations, , Romania

Many Locations, , South Africa

Many Locations, , Syria

Many Locations, , Ukraine

Many Locations, , Venezuela

Countries

Albania; Bosnia and Herzegovina; Colombia; Croatia; Czechia; Jordan; Lebanon; Moldova; North Macedonia; Romania; South Africa; Syria; Ukraine; Venezuela

Other Identifiers

MA0901

Identifier Type: OTHER

Identifier Source: secondary_id

MA0701-14697

Identifier Type: OTHER

Identifier Source: secondary_id

14536

Identifier Type: -

Identifier Source: org_study_id