title: Efficacy and bleeding profile of a combined oral contraceptive containing oestradiol valerate/dienogest: a pooled analysis of three studies conducted in North America and Europe.
abstract: OBJECTIVE
  To summarise all clinical data on the contraceptive efficacy and bleeding profile associated with an oestradiol valerate (E2V) and dienogest (DNG) [E2V/DNG] combined oral contraceptive (COC) derived from Phase III trials.
  
  
  METHODS
  Pooled analysis of three large-scale multicentre trials conducted in healthy women who received oral E2V/DNG for 7 to 28 cycles (28-day cycles).
  
  
  RESULTS
  A total of 2266 women were included in this analysis. Overall, 19 pregnancies occurred over 13 cycles during 880,950 days of relevant exposure (Pearl Index [PI] of 0.79; upper limit of the two-sided 95% confidence interval [CI]: 1.23). Ten pregnancies attributed to method failure came about during 871,091 days of relevant exposure (adjusted PI of 0.42; upper limit of the two-sided 95% CI: 0.77). In women aged 18 to 35 years (n = 1687), the corresponding PI and adjusted PI were 1.01 (upper limit of the two-sided 95% CI: 1.59) and 0.51 (upper limit of the two-sided 95% CI: 0.97), respectively. In the first 13 cycles of treatment, 76 to 81% of women experienced scheduled withdrawal bleeding, and 13 to 23% experienced intracyclic bleeding.
  
  
  CONCLUSIONS
  E2V/DNG provides reliable contraceptive efficacy in women aged 18 to 50 years.
authors: Department of Obstetrics and Gynecology, Harbor-UCLA Medical Center, Torrance, CA, USA. anitalnelson@earthlink.net
authors: Anita
authors: A
authors: Nelson
authors: Susanne
authors: S
authors: Parke
authors: Dagmar
authors: D
authors: Makalova
authors: Marco
authors: M
authors: Serrani
authors: Santiago
authors: S
authors: Palacios
authors: Uwe
authors: U
authors: Mellinger
mesh_terms: D000293:Adolescent; D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D003267:Contraception / Q000379:methods*; D003276:Contraceptives, Oral / Q000627:therapeutic use*; D004338:Drug Combinations; D004958:Estradiol / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D005060:Europe; D005260:Female; D006801:Humans; D008598:Menstruation / Q000187:drug effects; D008796:Metrorrhagia / Q000209:etiology; D008875:Middle Aged; D009277:Nandrolone / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D009656:North America; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003276:Contraceptives, Oral; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; D004958:Estradiol; D009277:Nandrolone