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.
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.