title: Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial.
abstract: OBJECTIVE
  To compare a new low-dose levonorgestrel and ethinyl estradiol contraceptive patch (Patch) with a combination oral contraceptive (Pill; 100 micrograms levonorgestrel, 20 micrograms ethinyl estradiol) regarding efficacy, safety, compliance, and unscheduled uterine bleeding.
  
  
  METHODS
  Women (17-40 years; body mass index 16-60) were randomized in a 3:1 ratio to one of two groups: Patch only (13 cycles) or Pill (six cycles) followed by Patch (seven cycles). Investigators evaluated adverse events during cycles 2, 4, 6, 9, and 13. Participants recorded drug administration and uterine bleeding on daily diary cards. Compliance was assessed by measuring levonorgestrel and ethinyl estradiol plasma levels. Pearl Index (pregnancies per 100 woman-years) was calculated to evaluate efficacy.
  
  
  RESULTS
  Participants (N=1,504) were randomized to Patch (n=1,129) or Pill (n=375). Approximately 30% were obese, more than 40% were racial or ethnic minorities, and more than 55% were new users of hormonal contraceptives. Laboratory-verified noncompliance (undetectable plasma drug levels) was 11% of Patch and 12.6% of Pill users at cycle 6. Pearl Indices (95% confidence intervals) for the intention-to-treat population (cycles 1-6) were 4.45 (2.34-6.57) for Patch and 4.02 (0.50-7.53) for Pill; excluding laboratory-verified noncompliant participants, Pearl Indices were 2.82 (0.98-4.67) for Patch and 3.80 (0.08-7.52) for Pill (differences not statistically significant). Incidence of unscheduled bleeding and incidence and severity of adverse events were similar for both contraceptives (no statistically significant difference).
  
  
  CONCLUSIONS
  Efficacy and safety of the new contraceptive Patch are comparable to those of a Pill. Laboratory-verified noncompliance and bleeding profile are similar between the two treatments. The Patch was well tolerated.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT01181479.
  
  
  METHODS
  I.
authors.affiliation: Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, Florida; the Columbus Center for Women's Health Research, Columbus, Ohio; Mailman School of Public Health, Columbia University, New York, New York; the Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, Virginia; the Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, California; ARSTAT, Flemington, New Jersey; and Agile Therapeutics, Inc, Princeton, New Jersey.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Kaunitz
authors.forename: David
authors.initials: D
authors.lastname: Portman
authors.forename: Carolyn L
authors.initials: CL
authors.lastname: Westhoff
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Mishell
authors.forename: Arkady
authors.initials: A
authors.lastname: Rubin
authors.forename: Marie
authors.initials: M
authors.lastname: Foegh
mesh_terms: D000293:Adolescent; D000328:Adult; D015992:Body Mass Index; D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D005006:Ethnicity; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D009765:Obesity; D010349:Patient Compliance; D011247:Pregnancy; D057968:Transdermal Patch / Q000009:adverse effects; D016896:Treatment Outcome; D014592:Uterine Hemorrhage; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C072593:ethinyl estradiol, levonorgestrel drug combination; D004997:Ethinyl Estradiol; D016912:Levonorgestrel