Mirena IUD Approved for Up to 7 Years of Pregnancy Prevention
The Food and Drug Administration (FDA) has expanded approval of the Mirena levonorgestrel-releasing intrauterine device (IUD) for up to 7 years of pregnancy prevention. Previously, the Mirena IUD was indicated for contraception for up to 6 years.
The approval was based on data from the phase 3 Mirena Extension Trial (ClinicalTrials.gov Identifier: NCT02985541) that evaluated the efficacy of Mirena during extended use beyond 5 years. The study included 362 women aged 18 to 35 years who had been using Mirena for not less than 4.5 years and no more than 5 years at enrollment. This an important step in providing an expanded range of long-acting reversible contraception options to users globally. Additional information is available here.