title: Fertility and combined oral contraceptives - unintended pregnancies and planned pregnancies following oral contraceptive use - results from the INAS-SCORE study.
abstract: OBJECTIVE
  To estimate the real-use contraceptive effectiveness of the combined oral contraceptive containing dienogest and estradiol valerate (DNG/EV) and whether DNG/EV compared to other combined oral contraceptives (oCOC) has a negative effect on return to fertility.
  
  
  METHODS
  Transatlantic, prospective, non-interventional cohort study conducted in the USA and seven European countries with two main exposure groups and one exposure subgroup: new users of DNG/EV and other COC (oCOC), particularly levonorgestrel-containing COCs (LNG). In a planned secondary analysis, pregnancy outcomes were investigated including contraceptive effectiveness and pregnancy following contraceptive cessation. The influence of age, parity and OC-type were assessed.
  
  
  RESULTS
  50,203 COC users were followed for 105,761 woman-years (WY). There were 677 unintended pregnancies reported: 451 in the USA and 226 in Europe. The contraceptive failure rate in Europe was 0.5 events/100 WY (95% CI: 0.4-0.5) and in the USA 1.9 events/100 WY (95% CI: 1.7-2.1). Differences in compliance (1.3 pregnancies/100 WY) accounted for 90% of the geographical difference seen between Europe and the USA. DNG/EV showed lower contraceptive failure rates compared to the comparators; 0.9% DNG/EV, 2.1% oCOC and 2.8% LNG after 4 years. Overall, 1167 (2.3%) of women stopped contraceptive use with the intention of becoming pregnant with 89% conceiving within 2 years. No significant differences were seen between groups after adjusting for age.
  
  
  CONCLUSIONS
  DNG/EV is associated with similar contraceptive effectiveness in typical-use settings when compared to oCOC and LNG. There was no difference observed between cohorts in fertility following OC use.
authors.affiliation: a ZEG - Berlin Center for Epidemiology and Health Research , Berlin , Germany.
authors.forename: Clare
authors.initials: C
authors.lastname: Barnett
authors.affiliation: a ZEG - Berlin Center for Epidemiology and Health Research , Berlin , Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Hagemann
authors.affiliation: b Pharmacoepidemiology Berlin , Berlin , Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Dinger
authors.affiliation: a ZEG - Berlin Center for Epidemiology and Health Research , Berlin , Germany.
authors.forename: Thai
authors.initials: T
authors.lastname: Do Minh
authors.affiliation: a ZEG - Berlin Center for Epidemiology and Health Research , Berlin , Germany.
authors.forename: Klaas
authors.initials: K
authors.lastname: Heinemann
mesh_terms: D000328:Adult; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives; D005060:Europe; D005260:Female; D005298:Fertility / Q000187:drug effects*; D005500:Follow-Up Studies; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives; D011247:Pregnancy; D018873:Pregnancy Rate; D049168:Pregnancy, Unplanned; D011446:Prospective Studies; D014481:United States; D028761:Withholding Treatment / Q000706:statistics & numerical data*; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; D004958:Estradiol; D016912:Levonorgestrel; D009277:Nandrolone
keywords: Pearl Index; Prospective cohort study; active surveillance; contraceptive effectiveness; dienogest; estradiol valerate