Turok DK, Nelson AL, Dart C, et al. - Researchers investigated the efficacy, safety, and tolerability of a new, low-dose copper (175 mm²) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator in parous and nulliparous women. This commercially funded project was approved by institutional review boards at 12 US sites. For a copper-based intrauterine device (IUD), standard inclusion and exclusion criteria were met by the patients; these criteria were generally consistent with the Centers for Disease Control and Prevention's US Medical Eligibility Criteria for Contraceptive Use, 2016. Data concerning a total of 5,640 cycles evaluable for pregnancy were provided by 286 women (average age: 27.1 years; nulliparous women: 60.8%). Two pregnancies and 10 serious adverse events (none were study-related) were identified over 36 months of observation. Observations in this phase 2 US Food and Drug Administration trial demonstrate that the novel, low-dose copper and nitinol IUD is highly efficacious and safe.