Agile Therapeutics has reported the successful completion of a Phase II clinical trial of a new low-estrogen contraceptive patch. The trial results demonstrated effective ovulation suppression.
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. In recent years, treatment trends have moved towards lower hormone exposure. Agile's patch is designed to deliver levonorgestrel and ethinyl estradiol, the same hormone combination found in many oral contraceptives with well-established safety records. Estrogen levels with the Agile patch are comparable to low-dose oral contraceptives containing 20 to30 ug of estrogen.