MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01085487

Collaborator

(none)

1,211

Enrollment

Locations

Duration (Months)

86.5

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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 or Disease	Intervention/Treatment	Phase
Idiopathic Menorrhagia	Drug: Levonorgestrel (Mirena, BAY86-5028) Drug: Hormonal treatment Drug: Antifibrinolytic 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 (NCT00864136), 14536.

Study Design

Study Type:

Observational

Actual Enrollment :

1211 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia (MA0901)

Study Start Date :

Apr 1, 2009

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia [12 months]

Secondary Outcome Measures

Bleeding pattern [12 months]
Patient satisfaction at end of documentation [12 months]
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.) [12 months]
Safety profile (adverse events) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	City	Country
1	Many Locations	Albania
2	Many Locations	Bosnia and Herzegovina
3	Many Locations	Colombia
4	Many Locations	Croatia
5	Many Locations	Czech Republic
6	Many Locations	Jordan
7	Many Locations	Lebanon
8	Many Locations	Macedonia, The Former Yugoslav Republic of
9	Many Locations	Moldova, Republic of
10	Many Locations	Romania
11	Many Locations	South Africa
12	Many Locations	Syrian Arab Republic
13	Many Locations	Ukraine
14	Many Locations	Venezuela

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01085487

Other Study ID Numbers:

14536
MA0901
MA0701-14697

First Posted:

Mar 12, 2010

Last Update Posted:

Apr 10, 2012

Last Verified:

Apr 1, 2012

Keywords provided by , ,

Menorrhagia

Additional relevant MeSH terms:

Menorrhagia

Antifibrinolytic Agents

Levonorgestrel

Study Results

No Results Posted as of Apr 10, 2012