Agile Therapeutics reports additional data from Phase 3 Twirla study
Agile Therapeutics announced the presentation of additional results of its Phase 3 SECURE trial of its investigational low-dose combination hormone contraceptive patch, Twirla. The summary of SECURE clinical trial results, which included new data on the bleeding profile of clinical trial subjects, was presented at the Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists. Regarding the bleeding profile, analyses demonstrated that unscheduled bleeding/spotting days per month decreased from a mean of 3.1 days in Cycle 1 to 1.6 days in Cycle 13. In addition, scheduled bleeding/spotting remained consistent during all cycles, with a reported mean of 3.1 to 3.7 days per month. "We are pleased with the results of the SECURE trial and believe our study may set a new standard for hormonal contraceptive studies. Our study entry criteria resulted in the inclusion of a real-world study population, including women who have frequently been underrepresented in past contraceptive studies," noted Agile.