52 mg Levonorgestrel IUD is a hormonal, levonorgestrel-releasing, long-acting reversible contraceptive. 52 mg Levonorgestrel IUD is differentiated from existing hormone-releasing IUDs by the next-generation frame made of flexible, super-elastic nitinol that can conform to different uterine shapes and sizes.1,2
A three-year, Phase 2 multi-center trial has been completed demonstrating the safety and efficacy of investigational 52 mg Levonorgestrel IUD for prevention of pregnancy.3
References
1. ClinicalTrials.gov. Evaluation of the Efficacy, Safety, and Tolerability of LevoCept. Updated April 12, 2022. Accessed October 11, 2022. https://clinicaltrials.gov/ct2/show/NCT04457076
2. U.S. Food & Drug Administration. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol Guidance for Industry and Food and Drug Administration Staff. Issued on July 9, 2021. Accessed on October 8, 2022. https://www.fda.gov/media/123272/download
3. ClinicalTrials.gov. Evaluation of the Efficacy and Safety of LevoCept. Updated April 12, 2022. Accessed October 12, 2022. https://clinicaltrials.gov/ct2/show/NCT02882191?term=levocept%27&draw=2&rank=1