Levonorgestrel-releasing intrauterine system versus conventional medical therapy for heavy menstrual bleeding in the Asia-Pacific region.

OBJECTIVE

To compare clinical outcomes, including cumulative continuation rate (CCR), in the treatment of idiopathic heavy menstrual bleeding (HMB) with the levonorgestrel-releasing intrauterine system (LNG-IUS) and with conventional medical therapies (CMTs), including combined oral contraceptives, oral progestins, and antifibrinolytics, either alone or in combination, in the Asia-Pacific region.

METHODS

In a prospective observational cohort study conducted between September 2008 and December 2010, 647 women (LNG-IUS, n=483; CMTs, n=164), aged 18-45 years and diagnosed with HMB, were recruited from 8 countries and followed for up to 1 year. The primary outcome was the CCR at 12 months. Secondary outcomes included bleeding pattern, an assessment of treatment efficacy by the treating physician, and safety.

RESULTS

The CCR at 12 months was significantly higher for LNG-IUS than for CMTs (87.6% vs 56.3% P<0.05). Compared with CMTs, LNG-IUS offered a better reduction in both subjectively assessed menstrual blood loss and the number of bleeding days, and had better efficacy for HMB, as determined by the physician's final evaluation.

CONCLUSION

The present study provides information on the real-life patterns of treatment of HMB in the Asia-Pacific region. The efficacy of CMTs was inferior compared with LNG-IUS in the clinical outcomes measured. ClinicalTrials.gov:NCT00864136.