title: Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data.
abstract: OBJECTIVE
  To present efficacy and cycle control data pooled from three pivotal studies of the contraceptive patch (Ortho Evra/Evra).
  
  
  METHODS
  Three multicenter, open-label, contraceptive studies that included up to 13 treatment cycles.
  
  
  METHODS
  183 centers.
  
  
  METHODS
  3,319 women.
  
  
  METHODS
  Three consecutive 7-day patches (21 days) with 1 patch-free week per cycle.
  
  
  METHODS
  Contraceptive efficacy and cycle control.
  
  
  RESULTS
  Overall and method failure life-table estimates of contraceptive failure through 13 cycles were 0.8% (95% CI, 0.3%-1.3%) and 0.6% (95% CI, 0.2%-0.9%), respectively. Corresponding Pearl indices were 0.88 (95% CI, 0.44-1.33) and 0.7 (95% CI, 0.31-1.10). Contraceptive failure among women with a body weight < 90 kg (<198 lb) was low and uniformly distributed across the weight range. A subgroup of women with body weight > or = 90 kg (> or = 198 lb) may have increased risk of pregnancy. The incidence of breakthrough bleeding was low and decreased over time.
  
  
  CONCLUSIONS
  In contraceptive patch users, the overall annual probability of pregnancy was 0.8% and the method failure probability was 0.6%. The efficacy of the patch was high and similar across age and racial groups. Among women < 90 kg (<198 lb), contraceptive failure was low and uniformly distributed across the range of body weights. In women > or = 90 kg (> or = 198 lb), contraceptive failures may be increased. Efficacy and cycle control have been shown to be comparable to an established oral contraceptive.
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia, USA.
authors.forename: Miriam
authors.initials: M
authors.lastname: Zieman
authors.forename: John
authors.initials: J
authors.lastname: Guillebaud
authors.forename: Edith
authors.initials: E
authors.lastname: Weisberg
authors.forename: Gary A
authors.initials: GA
authors.lastname: Shangold
authors.forename: Alan C
authors.initials: AC
authors.lastname: Fisher
authors.forename: George W
authors.initials: GW
authors.lastname: Creasy
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001835:Body Weight; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000592:standards; D004338:Drug Combinations; D016503:Drug Delivery Systems; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000592:standards; D005003:Ethisterone / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D011247:Pregnancy; D016016:Proportional Hazards Models
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D005003:Ethisterone; C449219:norelgestromin