title: A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra).
abstract: OBJECTIVE
  To review the safety and tolerability of the contraceptive patch (Ortho Evra/Evra) versus a standard oral contraceptive (Triphasil) and to present the pooled safety and tolerability of the patch across three pivotal studies.
  
  
  METHODS
  Three open-label, contraceptive studies of up to 13 treatment cycles.
  
  
  METHODS
  183 centers.
  
  
  METHODS
  Comparative study (812 patch, 605 oral contraceptive); pooled analysis (3,330 patch).
  
  
  METHODS
  The patch regimen was three consecutive 7-day patches (21 days) followed by 1 patch-free week per cycle; the oral contraceptive was dosed according to the U.S. physician package insert.
  
  
  METHODS
  Adverse events, laboratory tests, vital signs, and body weight.
  
  
  RESULTS
  The incidence of most events was similar between the patch and oral contraceptive groups, with the exception of a higher incidence of application site reactions, breast discomfort (cycles 1 and 2 only), and dysmenorrhea in the patch group. Pooled analysis demonstrated that most application site reactions (92%) and breast symptoms (86%) were mild or moderate in severity, and <2% of participants discontinued the patch because of either event. Only 7 (0.2%) participants experienced a serious adverse event classified as possibly, probably, or likely related to the patch. The mean change in body weight from baseline to the end of treatment was an increase of 0.3 kg.
  
  
  CONCLUSIONS
  Overall, the contraceptive patch is well tolerated and has a side effect profile similar to an established oral contraceptive.
authors.affiliation: University of Cincinnati, College of Medicine, Cincinnati, Ohio, USA.
authors.forename: Baha M
authors.initials: BM
authors.lastname: Sibai
authors.forename: Viveca
authors.initials: V
authors.lastname: Odlind
authors.forename: Mary L
authors.initials: ML
authors.lastname: Meador
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; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects* / Q000592:standards; D004338:Drug Combinations; D016503:Drug Delivery Systems; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards; D005003:Ethisterone / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D011247:Pregnancy
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination; D005003:Ethisterone; C449219:norelgestromin