Agile Therapeutics dosed first patient in the trial and also expects to recruit up to 1500 women over 100 sites throughout the US.
Agile’s lead contraceptive patch AG200-15 delivers a low dose of estrogen (ethinyl estradiol (EE)) in combination with levonorgestrel (LNG).
In a Phase 2 trail, the patch showed positive results and met its primary endpoint.
Marie Foegh, chief medical officer and vice president of clinical research and development at Agile, said: “AG200-15 has been designed to maximise both safety and tolerability for women, delivering EE at a dose which can provide a favorable bleeding profile.”
Thomas Rossi, president and CEO of Agile, said: “We are pleased with the progress of our lead AG200-15 program and the initiation of the pivotal, Phase 3 New Choice Study.
“We anticipate enrollment into the study will be rapid, driven by women’s desire for greater convenience and ease of compliance in their choice of contraception.”
