Additional results reported from Phase III SECURE trial of Twirla contraceptive patch- Agile Therapeutics

Agile Therapeutics announced the presentation of additional results of its Phase III SECURE trial of its investigational low-dose combination hormone contraceptive patch, Twirla (AG200-15). It reported analyses on the bleeding profile, which 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. It also included new data on the bleeding profile of clinical trial subjects. A summary of SECURE clinical trial results was presented at the 2017 Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists.

Comment: The Phase III SECURE study was a multicenter, single-arm, open-label, 13 cycle trial designed to evaluate the efficacy, safety and tolerability of AG200-15, also known as Twirla, in 2032 healthy women, aged 18 years and over, at 102 investigational sites across the United States.The trial also had broad entry criteria, placed no limitations on BMI or other demographic factors during enrollment, and enrolled a large and diverse patient population in order to allow efficacy to be assessed across different, real-world groups, as requested by the FDA. These entry criteria resulted in the inclusion of a substantial number of women with a high BMI, who have frequently been underrepresented in past contraceptive studies.