title: Safety and tolerability of a new low-dose contraceptive patch in obese and nonobese women.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville, Jacksonville, FL. Electronic address: andrew.kaunitz@jax.ufl.edu.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Kaunitz
authors.affiliation: Department of Obstetrics and Gynecology, Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA.
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.affiliation: Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Mishell
authors.affiliation: Agile Therapeutics, Inc, Princeton, NJ.
authors.forename: Marie
authors.initials: M
authors.lastname: Foegh
mesh_terms: D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects*; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage / Q000009:adverse effects*; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects*; D009644:Norgestrel / Q000009:adverse effects / Q000031:analogs & derivatives; D009765:Obesity; D063868:Patient Outcome Assessment; D057968:Transdermal Patch; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D003278:Contraceptives, Oral, Hormonal; D004338:Drug Combinations; C511292:Ortho Evra; C072593:ethinyl estradiol, levonorgestrel drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D016912:Levonorgestrel
keywords: Ortho Evra; Twirla; combination oral contraceptive; contraceptive patch; obese