A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra)

Fertil Steril. 2002 Feb;77(2 Suppl 2):S19-26. doi: 10.1016/s0015-0282(01)03264-2.


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.

Design: Three open-label, contraceptive studies of up to 13 treatment cycles.

Setting: 183 centers.

Patient(s): Comparative study (812 patch, 605 oral contraceptive); pooled analysis (3,330 patch).

Intervention(s): 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.

Main outcome measure(s): Adverse events, laboratory tests, vital signs, and body weight.

Result(s): 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.

Conclusion(s): Overall, the contraceptive patch is well tolerated and has a side effect profile similar to an established oral contraceptive.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Contraceptives, Oral, Combined / administration & dosage
  • Contraceptives, Oral, Combined / adverse effects*
  • Contraceptives, Oral, Combined / standards
  • Drug Combinations
  • Drug Delivery Systems*
  • Ethinyl Estradiol / administration & dosage
  • Ethinyl Estradiol / adverse effects*
  • Ethinyl Estradiol-Norgestrel Combination / administration & dosage
  • Ethinyl Estradiol-Norgestrel Combination / adverse effects
  • Ethinyl Estradiol-Norgestrel Combination / standards
  • Ethisterone / analogs & derivatives
  • Female
  • Humans
  • Middle Aged
  • Norgestrel / analogs & derivatives
  • Oximes
  • Pregnancy


  • Contraceptives, Oral, Combined
  • Drug Combinations
  • Oximes
  • Norgestrel
  • Ethinyl Estradiol
  • Ethinyl Estradiol-Norgestrel Combination
  • Ethisterone
  • norelgestromin