New Long-Acting Reversible Contraceptive Approved

The approval was based on a trial that included 1,452 women aged 18-35 years old
The approval was based on a trial that included 1,452 women aged 18-35 years old

Bayer announced that the Food and Drug Administration (FDA) has approved Kyleena (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to 5 years. 

Kyleena, a progestin-containing intrauterine system (IUS), is a small, flexible plastic T-shaped device that contains levonorgestrel. It is inserted by a healthcare provider during an in-office visit and prevents pregnancy for up to 5 years. Kyleena may be removed by a healthcare provider at any time. 

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Kyleena slowly releases levonorgestrel into a woman's uterus, resulting in slow amounts of the hormone entering the blood. Studies have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium.

The efficacy of Kyleena was studied in a multicenter, multi-national, randomized, open-label trial enrolling 1,452 women aged 18–35 years who received Kyleena. Of the 870 women who completed 3 years of the study, 707 chose to enroll in an extension phase up to a total of 5 years; 550 women completed 5 years of use. The primary efficacy endpoint used to assess contraceptive reliability was the pregnancy rate calculated as the Pearl Index (PI). The cumulative 5-year Kaplan Meier Rate was 1.45 (0.82, 2.53) based on 57,313 total evaluable 28-day cycles of exposure.

Kyleena contains levonorgestrel 19.5mg and will be available in October 2016.

For more information call (888) 842-2937 or visit Bayer.us.

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