Positive results were announced from a phase 3 trial evaluating a next-generation, low-dose copper intrauterine device (IUD) for the prevention of pregnancy.
The Copper 175mm2 IUD was investigated in a single-arm, open-label study (ClinicalTrials.gov Identifier: NCT03633799) that included women aged 17 through 45 years (60.1 % nulliparous and 39.9% parous). The primary endpoint of the trial was contraceptive efficacy through 3 years of use, as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over 1 year).
Findings showed that the trial met its primary endpoint, with a cumulative 3-year Pearl Index of 0.96 (95% CI, 0.59-1.48) in the efficacy cohort (n=1397). The most common adverse events reported included heavy menstrual bleeding, dysmenorrhea, and intermenstrual bleeding; 15.4% of patients discontinued use due to adverse events. Expulsion rates were reported to 1.9% in the first year and 0.9% in the third year. The overall placement success rate was 98.8%, indicating a positive experience for both clinicians and participants.
“This newly designed, flexible frame allows the Copper 175mm2 IUD to prevent pregnancies using less than half the amount of copper used in the only other copper IUD on the market,” said Principal Investigator David K. Turok, MD, MPH, Associate Professor, Department of Obstetrics and Gynecology, University of Utah. “The possibility of having another hormone-free IUD with low discontinuation rates due to pain and bleeding, as well as low expulsion rates, is exciting.”
The study remains ongoing and will assess effectiveness through 5 years. Additional data will be presented at the ACOG Annual Clinical & Scientific Meeting in Baltimore, MD.
Sebela Women’s Health announces positive phase 3 data for its investigational, next-generation, hormone-free, low-dose copper intrauterine device (IUD). News release. May 18, 2023. Accessed May 19, 2023. https://www.prnewswire.com/news-releases/sebela-womens-health-announces-positive-phase-3-data-for-its-investigational-next-generation-hormone-free-low-dose-copper-intrauterine-device-iud-301828219.html.