Data Support Five-year Use of Liletta
EXECUTIVE SUMMARY
Data from a recent analysis of the 52 mg levonorgestrel Liletta intrauterine device indicate its calculated levonorgestrel content and release rate curves support the continued evaluation of its contraceptive use for five or more years.
- The device is approved for three years of effective use; the company plans to seek regulatory approval for five years’ use.
- The device has been updated with a new single-handed inserter that allows use with either hand, a bendable tube to accommodate the anatomy of the patient during insertion, and the ability to reload the device if needed before insertion.
Data from a recent analysis of the 52 mg levonorgestrel Liletta intrauterine device (Medicines360, San Francisco, and Actavis, Dublin, Ireland) indicate its calculated levonorgestrel content and release rate curves support the continued evaluation of its contraceptive use for five or more years.1
“The study’s findings show that the amount of levonorgestrel remaining in the system and the amount still being released each year support the continued evaluation of Liletta as a contraceptive for up to five years,” says the study’s lead author, Mitchell Creinin, MD, professor and director of family planning in the Department of Obstetrics and Gynecology at the University of California, Davis.
The study results back Medicines360’s planned future FDA submission for a five-year duration of use for the device, states Jessica Grossman, MD, the company’s CEO.
Check The Data
To perform the analysis, researchers looked at clinical sites in Liletta’s U.S. Phase III study. Devices were analyzed from women who discontinued the trial. Samples were randomly selected to evaluate residual drug content within 90-day intervals after discontinuation through 900 days (approximately 2.5 years), and 180-day intervals for the remaining duration through 5.4 years (1,980 days). Scientists also performed an initial drug content analysis using 10 randomly selected samples from a single lot.
The study included 64 samples within 90-day intervals (range six to 10 samples per interval) through 900 days, and 36 samples within 180-day intervals (six samples per interval) for the remaining duration. The initial content analysis averaged 52.0 ± 1.8 mg. Scientists then calculated an average initial release rate of 19.5 mcg/day that decreased to 17.0, 14.8, 12.9, 11.3, and 9.8 mcg/day after one, two, three, four, and five years, respectively. The five-year average release rate was calculated 14.7 mcg/day.1
Device Updated with New Inserter
Liletta has just been updated with a new single-handed inserter that allows use with either hand, a bendable tube to accommodate the anatomy of the patient during insertion, and the ability to reload the device if needed before insertion. The launch and availability of the single- handed inserter follows the January 2016 FDA approval of the apparatus. Data were based on the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), conducted in the United States with 1,751 enrolled women receiving the device.2 During the ACCESS IUS clinical trial, the success rate for insertions with the new single-handed inserter was 99.2%.
The single-handed inserter features a locking mechanism within the cleft to keep the threads in place, a bendable tube to accommodate the anatomy of the patient during insertion, color-coded sliders to assist in loading the IUD and opening the arms during insertion, and the ability to reset the device for repeated attempts if the device is not loaded properly prior to insertion.
A video and companion material are available at Liletta’s provider website, www.lilettahcp.com, says Peter Schell, Medicines360 vice president. Reception of the new inserter, which has been presented at several national conferences, has been positive, he adds.
Review The Choices
The use of long-acting reversible contraception (LARC) has increased in recent years, from 2.4% of all women using contraception in 2002 to 11.6% in 2013.3,4 There are five LARC devices available in the United States: one single-rod etonogestrel implant (Nexplanon, Merck, Whitehouse Station, NJ) and five brands of IUDs. These include four levonorgestrel IUDs:
- the 52 mg Mirena (Bayer HealthCare Pharmaceuticals, Whippany, NJ), approved for the treatment of heavy menstrual bleeding in IUD users and for five years of contraceptive use;
- the 52 mg Liletta (Medicines360 and Actavis), approved for three years of contraceptive use;
- the 13.5 mg Skyla (Bayer), approved for three years of contraceptive use;
- the 19.5 mg Kyleena (Bayer), approved for five years of contraceptive use; and
- the ParaGard copper-T IUD (Teva Women’s Health, Sellersville, PA) is approved for 10 years of contraceptive use.
Intrauterine contraceptives and the contraceptive implant use is supported by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics. Both organizations have issued policy statements affirming that LARC methods are safe, effective, and appropriate options for teens.5,6
REFERENCES
- Creinin MD, Jansen R, Starr RM, et al. Levonorgestrel release rates over 5 years with the Liletta 52-mg intrauterine system. Contraception 2016;94:353-356.
- Eisenberg DL, Schreiber CA, Turok DK, et al. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception 2015;92:10-16.
- Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril 2012;98:893-897.
- Daniels K, Daugherty J, Jones J. Current contraceptive status among women aged 15-44: United States, 2011-2013. NCHS Data Brief 2014;(173):1-8.
- American College of Obstetricians and Gynecologists. Committee Opinion #539. Adolescents and long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol 2012;120:983-988.
- American Academy of Pediatrics, Committee on Adolescence. Policy statement: Contraception for adolescents. Pediatrics 2014;134:e1244-e1256.
Data from a recent analysis of the 52 mg levonorgestrel Liletta intrauterine device indicate its calculated levonorgestrel content and release rate curves support the continued evaluation of its contraceptive use for five or more years.
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