COPPER 175 mm2 IUD
(HORMONE-FREE PREGNANCY PREVENTION)

Phase 3 study underway

Copper 175 mm2 IUD is a hormone-free, copper-releasing, long-acting reversible contraceptive. Copper 175 mm2 IUD is made of nitinol with flexible and super-elastic properties that can conform to different uterine shapes and sizes and contains less than half the copper of the currently available copper IUD.1-3

Features of Copper 175 mm2 IUD include

  • Fully preloaded IUD in inserter
  • Small insertion tube diameter (3.7 mm) with tapered, rounded tip
  • Precut retrieval strings
  • Copper strategically placed near the ostia and internal os, so less is required for efficacy
  • Flexible, nitinol frame2

Phase 3 Design: Evaluation of Efficacy, Safety, and Tolerability of Copper 175 mm2 IUD

  • Prospective, multicenter, single-arm, open-label study to 3 years with extension up to 5 years
  • Study participants: N=1,620 subjects
  • Population: Postmenarcheal, premenopausal women up to 45 years old at risk for pregnancy; desiring a long-term intrauterine contraceptive for pregnancy prevention1

Copper 175 mm2 IUD is in Phase 3 clinical research. It is limited by United States Federal Law to investigational use.1

References

1. ClinicalTrials.gov. Evaluation of the Efficacy, Safety and Tolerability of VeraCept IUD. Updated June 23, 2022. Accessed September 23, 2022. https://clinicaltrials.gov/ct2/show/NCT03633799

2. Turok DK, Nelson AL, Dart C, et al. Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: phase 2 data to 36 months. Obstet Gynecol. 2020;135(4):840-847. doi:10.1097/AOG.0000000000003756

3. 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