title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Ian S
authors.initials: IS
authors.lastname: Fraser
authors.forename: Susanne
authors.initials: S
authors.lastname: Parke
authors.forename: Uwe
authors.initials: U
authors.lastname: Mellinger
authors.forename: Andrea
authors.initials: A
authors.lastname: Machlitt
authors.forename: Marco
authors.initials: M
authors.lastname: Serrani
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Jensen
mesh_terms: D000328:Adult; D003276:Contraceptives, Oral / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004958:Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D007501:Iron / Q000378:metabolism; D008595:Menorrhagia / Q000188:drug therapy*; D052576:Menstrual Hygiene Products / Q000706:statistics & numerical data; D008875:Middle Aged; D009277:Nandrolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
chemical_list: D003276:Contraceptives, Oral; D004338:Drug Combinations; C023635:dienogest; D004958:Estradiol; D009277:Nandrolone; D007501:Iron