BACKGROUND<\/p>\n
This double-blind trial investigated the efficacy and safety of estradiol valerate\/dienogest (E2<\/SUB>V\/DNG) for the treatment of heavy menstrual bleeding without recognizable organic pathology.<\/p>\n METHODS<\/p>\n 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 E2<\/SUB>V\/DNG or placebo for 196 days at 34 centres in Europe and Australia. The primary efficacy end-point was the proportion of women with a ‘complete’ response (i.e. a return to ‘menstrual normality’) during a 90-day efficacy phase. Secondary end-points included changes in measured menstrual blood loss (MBL) and iron metabolism parameters.<\/p>\n RESULTS<\/p>\n The intention-to-treat population comprised 231 women. The E2<\/SUB>V\/DNG response rate was much higher than with placebo (P<\/I> < 0.0001). The mean reduction in MBL volume in E2<\/SUB>V\/DNG recipients was 69.4% (median 79.2%) versus 5.8% (median 7.4%) in placebo recipients. The between-treatment difference in MBL volume was 373 ml in favour of E2<\/SUB>V\/DNG (95% confidence interval 490, 255 ml; P<\/I> < 0.0001). Significant improvements in iron metabolism parameters were observed with E2<\/SUB>V\/DNG but not placebo. Overall, 14 women (9.7%) treated with E2<\/SUB>V\/DNG and 5 (6.2%) treated with placebo prematurely discontinued treatment because of adverse events, headache being the most prevalent. Serious adverse events occurred in both the E2<\/SUB>V\/DNG and placebo groups (each n<\/I> = 2).<\/p>\n CONCLUSIONS<\/p>\n E2<\/SUB>V\/DNG is an effective treatment in women with heavy and\/or prolonged menstrual bleeding without organic pathology. Further study of E2<\/SUB>V\/DNG compared with an active comparator is warranted.<\/p>\n ClinicalTrials.gov identifier:<\/b> NCT00307801.<\/p>\n Source: BACKGROUND This double-blind trial investigated the efficacy and safety of estradiol valerate\/dienogest (E2V\/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 … Continue reading
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