title: The pharmacokinetics of 12-week continuous contraceptive patch use.
abstract: OBJECTIVE
  We sought to assess the change in serum ethinyl estradiol (EE2) and norelgestromin (NGMN) levels over 12 weeks of continuous contraceptive patch use.
  
  
  METHODS
  We asked participants (n=30) to apply consecutive patches to be worn continuously (without a patch-free interval) for 12 weeks. We collected blood samples at the end of each patch week and two times during weeks 4, 8, and 12 (with the additional blood draw occurring mid-week). Liquid chromatography-tandem triple quadrupole mass spectrometry (LC-MS/MS) was utilized to assess EE2 and NGMN levels.
  
  
  RESULTS
  Twenty-seven women completed the study; 26 were compliant with patch use. Ethinyl estradiol levels ranged from 0 to 193 pg/mL over the period. We observed an accumulation over the 12-week time at an estimated rate of 2.15 pg/mL per week (95% confidence interval 0.95-3.35, p<.001). The change in NGMN levels ranged from 0 to 2.52 ng/mL over the 12 weeks (95% confidence interval 0.021-0.019, p=.915). The most common side effects reported were vaginal spotting, breast tenderness and abdominal pain/cramping. There were no serious adverse events reported.
  
  
  CONCLUSIONS
  While the range of weekly EE2 values was quite wide, the absolute values remain low and generally within the expected range described in product labeling. Providers may consider prescribing continuous use of the patch, but given the slow accumulation of EE2 over time, 12 weeks should not be exceeded in the absence of safety data.
authors.affiliation: Department of Obstetrics & Gynecology, Boston Medical Center. Electronic address: aflavelanet@yahoo.com.
authors.forename: Antonella F
authors.initials: AF
authors.lastname: Lavelanet
authors.affiliation: Data Coordinating Center, BU School of Public Health.
authors.forename: Denis
authors.initials: D
authors.lastname: Rybin
authors.affiliation: Department of Obstetrics & Gynecology, Boston Medical Center.
authors.forename: Katharine O
authors.initials: KO
authors.lastname: White
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D015992:Body Mass Index; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000493:pharmacokinetics*; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D009644:Norgestrel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D010091:Oximes / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D013997:Time Factors; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; C449219:norelgestromin
keywords: Contraceptive patch; Ethinyl estradiol; Hormonal contraception; Norelgestromin; Pharmacokinetics