Mirena or Conventional Medical Treatment for Menorrhagia

Menorrhagia Clinical Trial

Official title:

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864136
• Other study ID #: 14697
• Secondary ID: MA0701MA0901 - n
• Status: Completed
• Phase: N/A
• First received: March 17, 2009
• Last updated: June 30, 2015
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: June 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeHong Kong: Ethics CommitteeIndonesia: Ethics CommmitteeKorea: Food and Drug AdministrationMalaysia: Ministry of HealthTaiwan: Institutional Review BoardThailand: Ethical CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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 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.

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, 14536 (NCT01085487).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 647
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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)

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Drug:
• Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for treatment of menorrhagia
• Conventional medical treatment
Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug
• Conventional medical treatment
Women using anti-fibrinolytic agent for treatment of menorrhagia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Hong Kong,  Indonesia,  Korea, Republic of,  Malaysia,  Pakistan,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia		at 12 months	No
Secondary	Bleeding pattern		at 12 months	No
Secondary	Patient satisfaction at end of documentation		at 12 months	No
Secondary	Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)		at 12 months	No
Secondary	Adverse events collection		at 12 months	Yes

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