title: Ethinyl estradiol and levonorgestrel in a transdermal contraceptive delivery system.
abstract: BACKGROUND
  The new transdermal contraceptive delivery system (TCDS) developed by Agile Therapeutics containing ethinyl estradiol and levonorgestrel (EE/LNG) is a reversible contraceptive method that maintains stable serum levels of both estrogen and progestin, and has efficacy similar to that of combination oral contraceptives (COC).
  
  
  METHODS
  We provided information of this new TCDS compared with the only TCDS available on the market that contains EE and norelgestromin, and has a higher EE exposure than a COC with 35 µg of EE potentially increasing the risk of venous thromboembolism. The article will summarize finding from clinical studies Phase I, II and III of EE/LNG TCDS.
  
  
  CONCLUSIONS
  The development of the lower dose EE/LNG TCDS has demonstrated less EE exposure. The serum levels of EE and LNG were stable and comparable between various application sites and daily life conditions. Moreover, the EE/LNG TCDS showed comparable efficacy among obese and non-obese users. However, the Pearl index of this EE/LNG TCDS is questionable and the problem of compliance is a potential confounder of the results. The current Phase III efficacy study will contribute to a further evaluation of compliance and efficacy and will be completed in 2016.
authors.affiliation: Chiang Mai University, Department of Obstetrics and Gynecology, Faculty of Medicine , Chiang Mai , Thailand.
authors.forename: Intira
authors.initials: I
authors.lastname: Sriprasert
authors.forename: Frank Z
authors.initials: FZ
authors.lastname: Stanczyk
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
mesh_terms: D002986:Clinical Trials as Topic; D003277:Contraceptives, Oral, Combined / Q000493:pharmacokinetics; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000493:pharmacokinetics; D006801:Humans; D016912:Levonorgestrel / Q000493:pharmacokinetics; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; C072593:ethinyl estradiol, levonorgestrel drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; C449219:norelgestromin
keywords: contraceptive patch; ethinyl estradiol; levonorgestrel; transdermal contraceptive delivery system