title: Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest.
abstract: BACKGROUND
  The study was conducted to assess the efficacy of estradiol valerate/dienogest (E₂V/DNG) administered using an estrogen step-down and progestogen step-up approach in a 28-day regimen in the treatment of heavy menstrual bleeding (HMB) using clinical end points allowing E₂V/DNG to be compared with other available medical therapies.
  
  
  METHODS
  This was a pooled analysis of data from two identically designed randomized, placebo-controlled, multiple center studies conducted in Europe, Australia and North America that assessed the effectiveness of E₂V/DNG in reducing menstrual blood loss (MBL) in women with HMB. Women aged ≥ 18 years with objectively confirmed HMB were randomized to E₂V/DNG (n=220) or placebo (n=135) for seven treatment cycles. Outcomes analyzed included absolute reduction in MBL from baseline, proportion of women successfully treated (defined as MBL below 80 mL and ≥ 50% reduction in MBL), proportion with MBL below 80 mL and proportion with ≥ 50% reduction in MBL from baseline.
  
  
  RESULTS
  At study end, 63.6% and 11.9% of patients were successfully treated with E₂V/DNG and placebo, respectively, with 68.2% and 15.6% of women with MBL below 80 mL, and 70.0% and 17.0% with MBL reduction ≥ 50% (all p<.001).
  
  
  CONCLUSIONS
  E₂V/DNG is highly effective for the treatment of HMB and is associated with a high rate of treatment success.
authors.affiliation: Department of Obstetrics and Gynaecology, University of Sydney, Sydney, New South Wales 2006, Australia.
authors.forename: Ian S
authors.initials: IS
authors.lastname: Fraser
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Jensen
authors.forename: Matthias
authors.initials: M
authors.lastname: Schaefers
authors.forename: Uwe
authors.initials: U
authors.lastname: Mellinger
authors.forename: Susanne
authors.initials: S
authors.lastname: Parke
authors.forename: Marco
authors.initials: M
authors.lastname: Serrani
mesh_terms: D000293:Adolescent; D000328:Adult; D000728:Androgens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008595:Menorrhagia / Q000188:drug therapy*; D008875:Middle Aged; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000728:Androgens; D003277:Contraceptives, Oral, Combined; D003278:Contraceptives, Oral, Hormonal; D004338:Drug Combinations; D004967:Estrogens; C454300:estradiol valerate-dienogest; D004958:Estradiol; D009277:Nandrolone