Ethinyl estradiol and levonorgestrel in a transdermal contraceptive delivery system.
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| Abstract | INTRODUCTION: 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). AREAS COVERED: 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. EXPERT OPINION: 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.
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| Authors | Intira Sriprasert, Frank Z Stanczyk, David F Archer |
| Journal | Expert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 16 Issue 12 Pg. 1901-9 ( 2015) ISSN: 1744-7666 [Electronic] England |
| PMID | 26194214 (Publication Type: Journal Article) |
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