title: Efficacy and safety of a combined oral contraceptive containing estradiol valerate/dienogest: results from a clinical study conducted in North America.
abstract: BACKGROUND
  This study investigated the efficacy and safety of a combined oral contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG).
  
  
  METHODS
  This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study conducted in the United States and Canada. Contraceptive efficacy was calculated as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; bleeding patterns were calculated based on bleeding and spotting information recorded daily in diary cards. Safety events during a 16-month extension study were added to the 1-year data.
  
  
  RESULTS
  In total, 499 women, aged 18-35 years, were enrolled, and 490 of them were included in the full analysis set for contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted Pearl Index=1.64). In cycles 1-12, an average 23.5% of women had absent scheduled (withdrawal) bleeding. Among women with scheduled (withdrawal) bleeding, bleeding started after a median of 2 days after intake of the last DNG-containing pill. For safety, data included from 147 women followed over an additional 16 months were added to the original 13-cycle data set. Treatment-related adverse events (AEs) occurred in 51.8% of women; 14.9% discontinued because of AEs over the entire 28-month study period.
  
  
  CONCLUSIONS
  A COC with E2V and DNG was shown to provide effective contraception in women aged 18-35 years in North America.
authors.affiliation: 1 Department of Obstetrics and Gynecology, Harbor-UCLA Medical Center , Torrance, California.
authors.forename: Anita
authors.initials: A
authors.lastname: Nelson
authors.forename: Susanne
authors.initials: S
authors.lastname: Parke
authors.forename: Uwe
authors.initials: U
authors.lastname: Mellinger
authors.forename: Edio
authors.initials: E
authors.lastname: Zampaglione
authors.forename: Anja
authors.initials: A
authors.lastname: Schmidt
mesh_terms: D000293:Adolescent; D000328:Adult; D002170:Canada; D003267:Contraception / Q000379:methods*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D034445:Ovulation Inhibition / Q000187:drug effects*; D011247:Pregnancy; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; D004958:Estradiol; D009277:Nandrolone