MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

NCT01085487 | Completed

• 3 other identifiers: 14536MA0901MA0701-14697
• Study Type: observational
• Target: 1,211
• Locations: 14 countries
• Sites: 14

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.

Conditions

Idiopathic Menorrhagia

Keywords

Menorrhagia

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (4)

• Bleeding pattern

  12 months

• Patient satisfaction at end of documentation

  12 months

• 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.)

  12 months

• Safety profile (adverse events)

  12 months

Study Arms (3)

Group 1

Drug: Levonorgestrel (Mirena, BAY86-5028)

Group 2

Drug: Hormonal treatment

Group 3

Drug: Antifibrinolytic treatment

Interventions

Levonorgestrel (Mirena, BAY86-5028) DRUG

Women using Mirena for treatment of menorrhagia

Group 1

Hormonal treatment DRUG

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

Group 2

Antifibrinolytic treatment DRUG

Antifibrinolytic treatment (such as tranexamic acid)

Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary care

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (14)

Unknown Facility

Many Locations, Albania

Location

Unknown Facility

Many Locations, Bosnia and Herzegovina

Location

Unknown Facility

Many Locations, Colombia

Location

Unknown Facility

Many Locations, Croatia

Location

Unknown Facility

Many Locations, Czechia

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, Moldova

Location

Unknown Facility

Many Locations, North Macedonia

Location

Unknown Facility

Many Locations, Romania

Location

Unknown Facility

Many Locations, South Africa

Location

Unknown Facility

Many Locations, Syria

Location

Unknown Facility

Many Locations, Ukraine

Location

Unknown Facility

Many Locations, Venezuela

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 12, 2010
• Study Start: April 1, 2009
• Study Completion: June 1, 2011
• Last Updated: April 10, 2012

Record last verified: 2012-04

Locations

JO (1); BO (1); RO (1); VE (1); AL (1); CR (1); NO (1); CO (1); SY (1); LE (1); MO (1); UA (1); CZ (1); ZA (1)