Liletta: New IUD approved by the FDA

The U.S. Food and Drug Administration (FDA) recently approved Liletta™, a new hormonal intrauterine device (IUD). This levonorgestrel-releasing IUD inhibits uterine lining from thickening and has been FDA approved for up to three years to prevent pregnancy. Liletta, found to be more than 99 percent effective, is already available in Europe and should arrive in the USA within the next few months.

Liletta was developed by Actavis and the non-profit Medicines360. Given the current high cost of IUDs, Medicines360 has focused on making Liletta affordable and accessible to all women. FDA approval was based on results from the largest hormonal IUD trial conducted in the U.S. The Section of Family Planning has been proud to participate in this study since 2010, as part of our broader commitment to research that improves contraceptive access for women.

Our previous research revealed various barriers in accessing the most effective methods, including cost. One recent study, conducted with support from the Office of Population Affairs, explored systems-level barriers to IUD provision. This research led to the development of a toolkit for clinical staff and health care providers to use in identifying and addressing barriers in their own clinics. We are also currently researching the feasibility and effectiveness of using mobile applications for contraceptive counseling in clinic waiting rooms. Our current studies follow previous research on an initial application, available here as an iOS app.

The Section supports the FDA’s approval of Liletta given its effectiveness at preventing pregnancy and ease of use for most women.

“Increasing the array of available and affordable contraceptive methods helps women find a method that best helps them achieve their reproductive health goals”, said Dr. Melissa Gilliam, Chief of the Section of Family Planning and lead investigator for the Section’s study site.

 

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