Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: A randomized, double-blind Phase III trial

I. S. Fraser, T. Römer, S. Parke, S. Zeun, U. Mellinger, A. MacHlitt, J. T. Jensen

Research output: Contribution to journalArticle

58 Scopus citations

Abstract

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 E 2V/DNG (95 confidence interval 490, 255 ml; P < 0.0001). Significant improvements in iron metabolism parameters were observed with E 2V/DNG but not placebo. Overall, 14 women (9.7) treated with E 2V/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.

Original languageEnglish (US)
Pages (from-to)2698-2708
Number of pages11
JournalHuman Reproduction
Volume26
Issue number10
DOIs
StatePublished - Oct 2011

Keywords

  • Dienogest
  • RCT
  • estradiol valerate
  • heavy and/or prolonged menstrual bleeding
  • oral contraceptive

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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