Safety and tolerability of a new low-dose contraceptive patch in obese and nonobese women

Am J Obstet Gynecol. 2015 Mar;212(3):318.e1-8. doi: 10.1016/j.ajog.2014.09.014. Epub 2014 Sep 16.


Objective: The safety and tolerability of a new low-dose levonorgestrel/ethinyl estradiol (LNG/EE) contraceptive patch was compared with 2 combination oral contraceptives in 2 clinical studies in which approximately 30% of enrolled participants were obese.

Study design: Two phase 3, open-label, randomized, parallel-group, multicenter trials compared the LNG/EE contraceptive patch (n = 1579) with combination oral contraceptives (n = 581) in healthy women 17-40 years of age. Combination oral contraceptives were LNG 100 μg per EE 20 μg (combination oral contraceptive 20; n = 375) or LNG 150 μg per EE 30 μg (combination oral contraceptive 30; n = 206). Safety and tolerability data from the 2 trials were evaluated in integrated safety analyses.

Results: Treatment-emergent adverse events of 2% or greater in the LNG/EE contraceptive patch were nasopharyngitis (5.2%), nausea (4.1%), upper respiratory infection (3.5%), headache (3.4%), sinusitis (2.9%), cervical dysplasia (2.3%), and urinary tract infection (2.1%). Including skin reaction-related treatment-emergent adverse events, the proportion of women who experienced any treatment-emergent adverse event was similar among women randomized to the contraceptive patch (47.5%), the combination oral contraceptive 20 (47.4%), or the combination oral contraceptive 30 (46.8%). The incidence of treatment-emergent adverse events was similar in obese vs nonobese participants in all groups. Serious adverse events occurred in less than 1% of participants in any of the treatment groups.

Conclusion: The LNG/EE contraceptive patch and combination oral contraceptives were well tolerated and associated with similar treatment-emergent adverse event incidences in obese and nonobese women.

Keywords: Ortho Evra; Twirla; combination oral contraceptive; contraceptive patch; obese.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Contraceptives, Oral, Combined / administration & dosage
  • Contraceptives, Oral, Combined / adverse effects*
  • Contraceptives, Oral, Hormonal / administration & dosage
  • Contraceptives, Oral, Hormonal / adverse effects*
  • Drug Combinations
  • Ethinyl Estradiol / administration & dosage
  • Ethinyl Estradiol / adverse effects*
  • Female
  • Humans
  • Levonorgestrel / administration & dosage
  • Levonorgestrel / adverse effects*
  • Norgestrel / adverse effects
  • Norgestrel / analogs & derivatives
  • Obesity*
  • Patient Outcome Assessment
  • Transdermal Patch*
  • Young Adult


  • Contraceptives, Oral, Combined
  • Contraceptives, Oral, Hormonal
  • Drug Combinations
  • Ortho Evra
  • ethinyl estradiol, levonorgestrel drug combination
  • Norgestrel
  • Ethinyl Estradiol
  • Levonorgestrel