Mirena or Conventional Medical Treatment for Menorrhagia

June 30, 2015 updated by: Bayer

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

647

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a diagnosis of idiopathic menorrhagia can be enrolled after decision for treatment has been made.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for treatment of menorrhagia
Group 2
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
Group 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding pattern
Time Frame: at 12 months
at 12 months
Patient satisfaction at end of documentation
Time Frame: at 12 months
at 12 months
Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)
Time Frame: at 12 months
at 12 months
Adverse events collection
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14697
  • MA0701 (Other Identifier: Company Internal)
  • MA0901 - non-East Asia (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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