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Mirena or Conventional Medical Treatment for Menorrhagia

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00864136
First received: March 17, 2009
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  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 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.


Condition Intervention
Menorrhagia
 Drug: Levonorgestrel (Mirena, BAY86-5028)
Drug: Conventional medical treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Bleeding pattern [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction at end of documentation [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 893
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Group 3 Drug: Conventional medical treatment
Women using anti-fibrinolytic agent for treatment of menorrhagia

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).

  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

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864136

Locations
China
Many Locations, China
Hong Kong
Many Locations, Hong Kong
Indonesia
Many Locations, Indonesia
Korea, Republic of
Many Locations, Korea, Republic of
Malaysia
Many Locations, Malaysia
Pakistan
Many Locations, Pakistan
Taiwan
Many Locations, Taiwan
Thailand
Many Locations, Thailand
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00864136     History of Changes
Other Study ID Numbers: 14697, MA0701, MA0901 - non-East Asia
Study First Received: March 17, 2009
Last Updated: October 17, 2012
Health Authority: China: Ethics Committee
Hong Kong: Ethics Committee
Indonesia: Ethics Commmittee
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Taiwan: Institutional Review Board
Thailand: Ethical Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
 Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on June 17, 2013