The levonorgestrel-releasing contraceptive is approved in the U.S. to be used to prevent pregnancy for up to four years.
The companies collected data from women who ranged from 16 – 45 years old. Two women, or 0.1% of study participants, experienced perforation following placement of the device and both were diagnosed within one year. Pelvic infection was found in 11 women and expulsion was reported in 63 participants, Allergan reported.
Just 2.3% of women discontinued use due to bleeding complaints over the course of five years.
The results of the five-year study were presented at this year’s meeting of the American College of Obstetricians and Gynecologists.
“We are encouraged by the presentation today at ACOG, which represents the data from our ongoing clinical trial used in our recent submission to the FDA requesting approval of Liletta for up to five years of use. This will, in turn, help us deliver on our mission of providing appropriate women of all socioeconomic levels the option of an effective long-acting reversible contraception,” Medicines360 CEO Dr. Jessica Grossman said in prepared remarks.