DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Mirena or Conventional Medical Treatment for Menorrhagia

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menorrhagia

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

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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 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.

Clinical Details

Official title: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia

Secondary outcome:

Bleeding pattern

Patient satisfaction at end of documentation

Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)

Adverse events collection

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Many Locations, China

Many Locations, Hong Kong

Many Locations, Indonesia

Many Locations, Korea, Republic of

Many Locations, Malaysia

Many Locations, Pakistan

Many Locations, Taiwan

Many Locations, Thailand

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Starting date: November 2008
Last updated: June 30, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017