The new low-dose transdermal contraceptive system (Twirla®): results from preclinical and Phase III trials.

Therapeutic Delivery
Anita L Nelson

Abstract

A new low-dose, once-a-week contraceptive transdermal delivery system (TDS) with 2.3-mg ethinyl estradiol (EE) and 2.6-mg levonorgestrel (LNG; Twirla®) has recently been approved by the US FDA for contraception of women with BMI <30 kg/m2. The rationale for developing this new patch, the preclinical study results and the results from two innovative Phase III clinical trials demonstrate that this patch has an acceptable Pearl index (4.3%) for its indicated users and has safety and tolerability comparable to other similar dose oral combined hormonal contraceptives. This new TDS provides an improvement over the existing TDS products, with significantly lower steady-state estrogen exposure, a level equal to that with 30-µg EE containing oral contraceptives.

References

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Feb 3, 2007·Obstetrics and Gynecology·J Alexander ColeAlexander M Walker
Mar 29, 2007·Journal of Clinical Pharmacology·Damayanthi DevineniAlbert T Leung
Jan 10, 2014·Obstetrics and Gynecology·Andrew M KaunitzMarie Foegh
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Aug 28, 2016·Fertility and Sterility·Katharine B Simmons, Alison B Edelman
Dec 5, 2017·Contraception and Reproductive Medicine·Roshni KakaiyaAnita L Nelson
Feb 2, 2018·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Monica V DragomanMary E Gaffield

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