MedTrace Logo

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

NCT01085487 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1211

Last updated 2012-04-10

No results posted yet for this study

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

Interventions

DRUG

Levonorgestrel (Mirena, BAY86-5028)

Women using Mirena for treatment of menorrhagia

DRUG

Hormonal treatment

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

DRUG

Antifibrinolytic treatment

Antifibrinolytic treatment (such as tranexamic acid)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Completion
2011-06-30

Countries

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

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01085487 on ClinicalTrials.gov