Idiopathic heavy and/or prolonged menstrual bleeding

BACKGROUND: The levonorgestrel-releasing intrauterine system (LNG-IUS) was first marketed in 1990 in Finland. Since then, it has been approved in approximately 120 countries throughout the world, with almost 50 million women-years of cumulative experience to date. Its high contraceptive effectiveness and favorable bleeding profile, leading to significant reduction of menstrual bleeding both in women with idiopathic menorrhagia and in those with normal menstrual bleedings, have been the key to the success of the system...

BACKGROUND: This double-blind trial investigated the efficacy and safety of estradiol valerate/dienogest (E(2)V/DNG) for the treatment of heavy menstrual bleeding without recognizable organic pathology. METHODS: Otherwise healthy women with idiopathic heavy, prolonged or frequent menstrual bleeding, confirmed during a 90-day run-in phase, were randomized (2:1) according to a permuted-block, computer-generated schedule to E(2)V/DNG or placebo for 196 days at 34 centres in Europe and Australia...