The company expects to complete the study in the second half of 2016. It is a multi-center, single-arm, open-label trial in healthy women at least 18 years old who will receive treatment with Twirla for abou an year.
It will evaluate the effectiveness of the patch in avoiding pregnancy using the Pearl Index as the primary contraceptive efficacy measure. The trail will also assess safety and tolerability.
Twirla contains a combination of ethinyl estradiol and levonorgestrel. The patch is applied once a week for three weeks followed by a week with no patch.
Agile Therapeutics chief medical officer Elizabeth Garner said: "Together with our partners and investigators, we now look forward to executing on this final, 12-month phase of the trial with continued focus on trial conduct and rigorous oversight, utilizing our technology platforms to support subject compliance and retention while minimizing loss to follow-up, all aimed at providing a high quality data package at the end of the trial."
Twirla is based on Agile’s transdermal patch technology, called Skinfusion, which is designed to provide advantages over currently available patches. It is aimed to optimizing patch adherence and patient acceptability.
The US hormonal contraceptive market had total market sales of $5.3bn in 2014, providing a better opportunity for Twirla.