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 run-in phase, were randomized (2:1) according to a permuted-block, computer-generated schedule to E₂V/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.

RESULTS

The intention-to-treat population comprised 231 women. The E₂V/DNG response rate was much higher than with placebo (P < 0.0001). The mean reduction in MBL volume in E₂V/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 E₂V/DNG (95% confidence interval 490, 255 ml; P < 0.0001). Significant improvements in iron metabolism parameters were observed with E₂V/DNG but not placebo. Overall, 14 women (9.7%) treated with E₂V/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 E₂V/DNG and placebo groups (each n = 2).

CONCLUSIONS

E₂V/DNG is an effective treatment in women with heavy and/or prolonged menstrual bleeding without organic pathology. Further study of E₂V/DNG compared with an active comparator is warranted.

ClinicalTrials.gov identifier: NCT00307801.

Source:
http://humrep.oxfordjournals.org/rss/current.xml