title: Hormone withdrawal-associated symptoms: comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate.
abstract: OBJECTIVE
  To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs).
  
  
  METHODS
  This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28.
  
  
  RESULTS
  In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E2V/DNG vs. 34% EE/NGM).
  
  
  CONCLUSIONS
  E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.
authors: Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, Oregon, USA.
authors: Jeffrey T
authors: JT
authors: Jensen
authors: Susanne
authors: S
authors: Parke
authors: Uwe
authors: U
authors: Mellinger
authors: Marco
authors: M
authors: Serrani
authors: R Garn
authors: RG
authors: Mabey
mesh_terms: D000328:Adult; D003276:Contraceptives, Oral / Q000009:adverse effects* / Q000494:pharmacology; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D004997:Ethinyl Estradiol / Q000009:adverse effects* / Q000494:pharmacology; D005260:Female; D006261:Headache / Q000209:etiology*; D006801:Humans; D008598:Menstruation / Q000187:drug effects; D009277:Nandrolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D009644:Norgestrel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D017699:Pelvic Pain / Q000209:etiology*; D013375:Substance Withdrawal Syndrome / Q000209:etiology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003276:Contraceptives, Oral; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; C109079:norgestimate, ethinyl estradiol drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D004958:Estradiol; D009277:Nandrolone