In the 23 women who completed the study, ovulation suppression, a widely accepted marker for effective pregnancy prevention, was achieved in 96% of the subjects.
Most contraceptive products contain both a progestin and estrogen, and are associated with certain common side effects, such as breast tenderness, bloating/weight gain and nausea. These side effects are believed to be related to the level of hormones delivered into the blood stream, particularly with higher levels of estrogen.
The FDA recently required a change to the labeling of Johnson & Johnson’s own contraceptive patch Ortho Evra, to reflect findings that the product delivers 60% more ethinyl estradiol than oral contraceptives containing 25-35 ug of estrogen.
“The goal of transdermal delivery is to smooth out the exposure to hormones by eliminating the daily peaks experienced immediately after taking oral contraceptive products,” reported Dr Hal Broderson, chief medical officer of Agile Therapeutics. “We are extremely pleased with these outcomes, as they indicate that our new low estrogen Agile patch would be effective in delivering low doses of both estrogen and progesterone to provide fertility control.”