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Mirena or Conventional Medical Treatment for Menorrhagia

NCT00864136 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 647

Last updated 2015-07-01

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 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.

Conditions

  • Menorrhagia

Interventions

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

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
2008-11-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • China
  • Hong Kong
  • Indonesia
  • Malaysia
  • Pakistan
  • South Korea
  • Taiwan
  • Thailand

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 NCT00864136 on ClinicalTrials.gov