INTRODUCTION:
AG200-15 is an investigational low-dose transdermal contraceptive patch being developed for prevention of pregnancy. AG200-15 is designed to deliver approximately 120 µg of LNG and 30 µg of EE per day, comparable to current low-dose oral contraceptives. AG200-15 is a 21-7 regimen, with patches applied once a week for three weeks, followed by a patch-free week. The Phase 3 Study to Evaluate Contraceptive Use, Reliability and Effectiveness (SECURE) was designed to assess efficacy, safety and tolerability of AG200-15.
METHODS:
SECURE was a single-arm, open-label, multicenter Phase 3 study of AG200-15 that enrolled approximately 2,000 reproductive-aged women to use the patch for up to one year. Primary efficacy was assessed using the Pearl Index in women 35 years of age and under. Cycles in which an alternate method of contraception was used or no sexual activity occurred were excluded. Safety and tolerability were assessed via adverse event reporting. An electronic diary was utilized for subject reporting of bleeding, patch site irritation, itching, and adhesion.
RESULTS:
Enrollment in SECURE began in September, 2014 and ended in October, 2015. Approximately 2,000 women were enrolled at 102 sites in the United States. The study population demographics were broadly representative of the population intended to use AG200-15. New users to hormonal contraception represented fewer than 20% of enrolled subjects. Top-line results including demographics, subject disposition, efficacy and safety will be available for ACOG 2017.
CONCLUSION:
The AG200-15 patch has the potential, if approved by the FDA, to provide women with a new low-dose combined hormonal contraceptive option.
