Clinical Trials Logo

Clinical Trial 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 Trial 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). ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00864136
Study type Observational
Source Bayer
Contact
Status Completed
Phase N/A
Start date November 2008
Completion date November 2010

See also
  Status Clinical Trial Phase
Completed NCT02824224 - Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) Phase 4
Withdrawn NCT01651468 - The Effect of the Nutraceutical "Hemofix" on the Coagulation System N/A
Recruiting NCT02616731 - Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD Phase 1/Phase 2
Terminated NCT02087228 - Evaluation of the Endometrial Cavity After Endometrial Ablation N/A
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01436903 - Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length Phase 4
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Completed NCT00160381 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT02228174 - Sonography Guided Transcervical Ablation of Uterine Fibroids N/A
Terminated NCT01969396 - Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology N/A
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT00393198 - Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia Phase 4
Completed NCT00966264 - Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia Phase 3
Completed NCT00904709 - The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Phase 4
Recruiting NCT03670680 - Efficiency of Lina LibrataTM System N/A
Completed NCT02584088 - Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
Completed NCT02835391 - PerClot Compared to Usual Care in Gynaecology Procedures N/A
Completed NCT02304510 - Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing