Phase III study of Liletta for contraception published in American Journal of Obstetrics & Gynecology.- Medicines360/Allergan.

Medicines360/Allergan announced newly published data finding that Liletta (levonorgestrel releasing intrauterine system) is highly efficacious in preventing pregnancy over five years of use. In addition, the publication reports data related to the bleeding profile of Liletta over the same time period. "Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52 mg Intrauterine System" was recently published online by the American Journal of Obstetrics & Gynecology. The findings are based on the largest ongoing Phase III intrauterine system (IUS) clinical trial in the U.S. The trial, "ACCESS IUS," (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), follows 1,751 U.S. women who received Liletta.

According to the study, Liletta is more than 99 percent effective in preventing pregnancy for up to five years in a broad range of women. Liletta is effective regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child). This latest study publication from the ACCESS IUS trial also describes rates of amenorrhea (defined as no bleeding or spotting in the preceding 90 days) for Liletta through five years of continued use. The study reported that nearly half (42 percent) of the women in the trial had amenorrhea at the end of five years of use. During the same time period, 90 percent of women experienced only amenorrhea, spotting, or light bleeding. In the trial, 2.2% of women discontinued the use of Liletta due to bleeding complaints.

See: Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System, Teal et al. American Journal of Obstetrics & Gynecology January 2019 - Volume 133 - Issue 1

Comment: Liletta was first approved in February 2015 with a two-handed inserter and received additional FDA approval in January 2016 for a new single-handed inserter.