52 mg LEVONORGESTREL IUD
(HORMONAL PREGNANCY PREVENTION)

Phase 3 ready

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

Features of 52 mg Levonorgestrel IUD include

  • Fully preloaded IUD in inserter
  • Small insertion tube diameter (3.7mm) with tapered, rounded tip
  • Precut retrieval strings
  • Flexible, nitinol frame1

Phase 3 Design: Evaluation of the Efficacy, Safety, and Tolerability of 52 mg Levonorgestrel IUD

  • Prospective, multicenter, single-arm, open-label study to 3 years with extension up to 5 years
  • Study participants: ≈1,525 subjects to be enrolled
  • Population: Postmenarcheal, premenopausal women up to 45 years old at risk for pregnancy; desiring a long-term intrauterine contraceptive for pregnancy prevention1

52 mg Levonorgestrel IUD is Phase 3 ready. It is limited by United States Federal Law to investigational use.1

References

1. ClinicalTrials.gov. Evaluation of the Efficacy, Safety, and Tolerability of LevoCept. Updated March 5, 2024. Accessed December 9, 2024. 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 December 9, 2024. https://clinicaltrials.gov/ct2/show/NCT02882191?term=levocept%27&draw=2&rank=1