MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01085487
First received: March 9, 2010
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Idiopathic Menorrhagia
Drug: Levonorgestrel (Mirena, BAY86-5028)
Drug: Hormonal treatment
Drug: Antifibrinolytic treatment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia (MA0901)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding pattern [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction at end of documentation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Impact of the therapy in terms of patient-reported health outcomes assessed using a validated questionnaire (Shaw RW et. al., British Journal of Obstetrics and Gynaecology, Vol 105(11), 1998.) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety profile (adverse events) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 1211
Study Start Date: April 2009
Study Completion Date: June 2011
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel (Mirena, BAY86-5028)
Women using Mirena for treatment of menorrhagia
Group 2 Drug: Hormonal treatment
Hormonal treatment (including combined oral contraceptives or oral or injectable progestogens)
Group 3 Drug: Antifibrinolytic treatment
Antifibrinolytic treatment (such as tranexamic acid)

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 (NCT00864136), 14536.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care

Criteria

Inclusion Criteria:

  • Women between the ages of 18-45 (inclusive) not intending to become 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085487

Locations
Albania
Many Locations, Albania
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Colombia
Many Locations, Colombia
Croatia
Many Locations, Croatia
Czech Republic
Many Locations, Czech Republic
Jordan
Many Locations, Jordan
Lebanon
Many Locations, Lebanon
Macedonia, The Former Yugoslav Republic of
Many Locations, Macedonia, The Former Yugoslav Republic of
Moldova, Republic of
Many Locations, Moldova, Republic of
Romania
Many Locations, Romania
South Africa
Many Locations, South Africa
Syrian Arab Republic
Many Locations, Syrian Arab Republic
Ukraine
Many Locations, Ukraine
Venezuela
Many Locations, Venezuela
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Healthcare
ClinicalTrials.gov Identifier: NCT01085487     History of Changes
Other Study ID Numbers: 14536, MA0901, MA0701-14697
Study First Received: March 9, 2010
Last Updated: April 9, 2012
Health Authority: Albania: Ministry of Health Department of Pharmacy
Bosnia: Federal Ministry of Health
Colombia: Ethics Committee
Czech Republic: State Institute for Drug Control
Croatia: Ethics Committee
Jordan: Ethical Committee
Lebanon: Institutional Review Board
Moldova: National Agency of Medicine; National Ethics Committee
Macedonia: Ministry of Health
Ukraine: Ministry of Health
Venezuela: Ethics Committee
Venezuela: Instituto Nacional de Higiene "Rafael Rangel" (MoH)
South Africa: Human Research Ethics Committee

Keywords provided by Bayer:
Menorrhagia

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Antifibrinolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on October 01, 2014