Agile closes active recruitment for phase three trial of new contraceptive patch

Agile Therapeutics Inc., a women's health specialty pharmaceutical company, on Monday announced active recruitment has closed in its ongoing single-arm, open-label Phase 3 SECURE clinical trial of Twirla, its investigational contraceptive patch.

"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," Al Altomari, president and CEO of Agile, said. "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."

Participating sites will complete screening over the next two weeks, and the company expects to complete enrollment by the end of the third quarter 2015.

"The Phase 3 SECURE clinical trial is progressing with continued focus on excellent study conduct," Elizabeth Garner, chief medical officer of Agile, said. "Our clinical investigators and their teams have worked diligently to identify quality subjects through the multi-step screening and enrollment process, which includes an electronic diary run-in period of no less than two weeks. In addition to successful completion of the eDiary run-in, all enrolled subjects must meet a number of entry criteria designed to optimize compliance with the study patch and electronic diary."