Agile Therapeutics Doses First Patients In Twirla Phase 3 SECURE Trial

(RTTNews) - Agile Therapeutics, Inc. (AGRX) announced that the first patients have been dosed in its SECURE trial. The SECURE study is a single-arm, open-label, multicenter Phase 3 trial that would evaluate the efficacy, safety and tolerability of Agile's investigational once-weekly transdermal contraceptive patch, Twirla.

"The successful dosing of the first patients marks a critical milestone in the SECURE development program. Throughout the planning of this trial, we focused on selecting the right investigators who will identify patients with a high potential for compliance and on implementing measures that will facilitate conducting a trial with rigor and close oversight," said Elizabeth Garner, M.D., M.P.H., Chief Medical Officer and Senior Vice President at Agile.

Nearly 2,100 female subjects are likely to be enrolled at up to 70 sites in the U.S. Patients meeting all eligibility criteria would use the patch for up to one year. The trial would assess the effectiveness of the patch in preventing pregnancy using the Pearl Index as the primary contraceptive efficacy measure. Also, safety and tolerability would be evaluated.

Twirla, an investigational prescription contraceptive patch, is a combined hormonal contraceptive patch that contains the active ingredients ethinyl estradiol and levonorgestrel, both of which have an established history of efficacy and safety in currently marketed combination low-dose oral contraceptives.