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Liletta remains safe, effective for pregnancy prevention after 5 years

Stephanie Teal

Liletta 52 mg intrauterine device continues to safely and effectively prevent pregnancies 5 years after successful placement, according to findings presented at the American College of Obstetricians and Gynecologists annual meeting.

“Our study group is assessing the long-term safety and efficacy of the Liletta 52 mg levonorgestrel-releasing intrauterine system for up to 10 years of use,” Stephanie Teal, MD, MPH, professor of obstetrics and gynecology at the University of Colorado School of Medicine, told Healio Internal Medicine.

Teal and colleagues enrolled 1,568 women aged between 16 and 35 years and 146 women aged between 36 and 45 years who had successful placement of Liletta. The researchers evaluated 5-year pregnancy rates in only the younger age group and safety outcomes in all participants.

Nearly 58% of women between 16 and 35 years were nulliparous and 25% were obese.

Nine pregnancies occurred, with one occurring after perforation and one after expulsion. Ectopic pregnancies were common and occurred in 67% of the pregnancies. The cumulative life-table pregnancy rate was 0.59 (95% CI, 0.28-1.25) at year 3 and 0.92 (95% CI, 0.46-1.82) at year 5.

Following the placement of Liletta, two women experienced perforation and 63 experienced expulsion, mostly within the first year. Eleven women were diagnosed with pelvic infection. Few women (2.3%) removed Liletta because of bleeding.

“After the first 5 years of use, the contraceptive system is very safe, and remains among the most efficacious of contraceptives, with a cumulative pregnancy rate of less than 1% over the 5 years,” Teal said. “This study is the largest IUD phase 3 clinical trial ever performed exclusively in the U.S. and provides solid data on how well this product works for most U.S. women, including nulliparous and obese women.”

She noted that the bleeding profile of Liletta is an advantage and that European studies showed even lower side effect rates. The low discontinuation rate due to bleeding complaints demonstrates how well Liletta performed, she said.

“Primary care providers can feel confident that the Liletta intrauterine system continues to be safe and effective after 5 years,” Teal said. – by Alaina Tedesco

Reference:

Teal SB, et al. Five-year efficacy and safety of the Liletta levonorgestrel intrauterine system. Presented at: American College of Obstetricians and Gynecologists Annual Meeting. April 27-30, 2018; Austin.

Disclosure: Teal reports receiving support from Bayer HealthCare and Medicines360 and consulting for Merck and Co. Please see abstract for all other authors’ relevant financial disclosures.