Agile completes patient recruitment in Twirla phase 3 SECURE clinical trial

The company will complete screening at participating sites in the next two weeks. Enrollment is anticipated to be completed by the end of the third quarter.

Twirla is the company’s lead product candidate and is a combined hormonal contraceptive patch that features the active ingredients ethinyl estradiol and levonorgestrel.

The company developed the product using its Skinfusion technology to deliver both hormones over a seven-day period at levels comparable to currently marketed low-dose oral contraceptives.

Agile Therapeutics president and CEO Al Altomari said: "We have completed active recruitment of patients into our Phase 3 SECURE clinical trial, which is a crucial milestone in the trial and for Agile.

"Together with all of our partners, including our CRO and manufacturing partner, we believe we have the right development plan in place to achieve our goal of making Twirla available as a convenient contraceptive option for women.

"We will continue our focus on quality management of the trial and execution of our broader business plan for developing women’s contraceptive products."

Under the SECURE study, about 2,100 female subjects will be enrolled to receive treatment for about one year.

The effectiveness of the patch will be examined in avoiding pregnancy using the Pearl Index as the primary contraceptive efficacy measure. The study also includes safety and tolerability assessment.