MiCo - Mirena or Conventional Medical Treatment for Menorrhagia
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01085487
First received: March 9, 2010
Last updated: April 9, 2012
Last verified: April 2012
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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:
MedlinePlus related topics:
Menstruation
Drug Information available for:
Levonorgestrel
U.S. FDA Resources
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
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 Antifibrinolytic Agents Levonorgestrel Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Hemostatics Coagulants Hematologic Agents Therapeutic Uses Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 23, 2013