NCT00864136

Mirena or Conventional Medical Treatment for Menorrhagia

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 647 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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, 14536 (NCT01085487).

Conditions

• Menorrhagia

Interventions

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

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-03-18
• Last updated: 2015-07-01

Locations

8 sites across 8 countries: China, Hong Kong, Indonesia, Malaysia, Pakistan, South Korea, Taiwan, Thailand