Skip to Content

Kyleena Approval History

Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to five years.

FDA approval of Kyleena was based on data from a Phase III clinical trial of 1452 generally healthy women aged 18 to 35. With a Pearl-Index of 0.29 after five years, Kyleena was more than 99 percent effective for each year of use in preventing pregnancy, and was generally well tolerated.

Kyleena is a small, soft and flexible plastic T-shaped device containing 19.5mg of levonorgestrel that is slowly released into the uterus. Kyleena provides effective birth control for up to five years, and also offers rapid return to a woman's natural level of fertility after removal.

Common side effects include vulvovaginitis, ovarian cysts, abdominal or pelvic pain, headache or migraine, acne or greasy skin, painful periods, sore or painful breasts, and increased bleeding.

Development History and FDA Approval Process for Kyleena

DateArticle
Sep 19, 2016Approval FDA Approves Bayer's Kyleena (Levonorgestrel-Releasing Intrauterine System) for Prevention of Pregnancy for up to Five Years

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide