The investigators reported one serious adverse event in the oral contraceptive group (one case with an unspecified liver problem) and three adverse events in the AG200-15 group (one case with a blood clot in the left subclavian vein, one case of uncontrollable nausea and vomiting, and one case of drug overdose with Benadryl) to be possibly or probably related to the study drug.
Going forward, Dr. Kaunitz said that he would like to see clinical trials of AG200-15 that involve shorter hormone intervals than the classic schedule of 21 active tablets followed by 7 hormone-free days as followed in this study. "Newer contraceptives tend to have shorter hormone-free intervals or be continuous," he said. "Going forward, I’d be interested in clinical trials of this patch using hormone-free intervals shorter than 7 days or cycles longer than 1 month."
Agile Therapeutics has submitted a New Drug Application for AG200-15 with the Food and Drug Administration.
The study was funded by Agile Therapeutics. Dr. Kaunitz disclosed that he is a consultant for the company.