Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: Pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest

Ian S. Fraser, Susanne Parke, Uwe Mellinger, Andrea MacHlitt, Marco Serrani, Jeffrey Jensen

Research output: Contribution to journalArticle

36 Scopus citations

Abstract

Objectives To evaluate the efficacy of oestradiol valerate/dienogest (E2V/DNG) for the treatment of heavy and/or prolonged menstrual bleeding without organic pathology based on the analysis of data from two identically designed double-blind, randomised studies. Methods Women aged ≥18 years with heavy and/or prolonged menstrual bleeding were randomised to E2V/DNG (n = 269) or placebo (n = 152) for 196 days. Objective changes in menstrual blood loss (MBL) volume were assessed using the alkaline haematin method. Results After six months of treatment, median MBL decreased by 88% with E2V/DNG compared with 24% with placebo. The greatest reduction was achieved at the first withdrawal bleed after treatment initiation and it was sustained with no loss of effect throughout treatment. Conclusion E2V/DNG was more effective than placebo in reducing MBL in women with heavy and/or prolonged menstrual bleeding without organic pathology. The reduction was largely achieved as early as the first withdrawal bleed, with further gradual improvement throughout treatment.

Original languageEnglish (US)
Pages (from-to)258-269
Number of pages12
JournalEuropean Journal of Contraception and Reproductive Health Care
Volume16
Issue number4
DOIs
StatePublished - Aug 1 2011

Keywords

  • Heavy menstrual bleeding
  • Oral contraceptive

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Pharmacology (medical)

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