A Phase 3 clinical trial has demonstrated promising results for a novel low-dose copper intrauterine device (IUD), potentially offering women the first new hormone-free contraceptive option in four decades. The study results, recently published in Contraception, show that the investigational Copper 175mm² IUD maintains high efficacy while utilizing less than half the copper content of currently available options.
The multicenter study, conducted across 42 U.S. research sites, evaluated the device's performance in women aged 17-45 years. Results showed a remarkably high placement success rate of 98.8% among 1,620 enrollees. The device demonstrated consistent contraceptive efficacy with a one-year Pearl Index of 0.94 (95% CI 0.43-1.78) and a three-year cumulative Pearl Index of 1.05 (95% CI 0.66-1.60).
"This uniquely designed, flexible copper IUD would be the first new hormone-free IUD available in 40 years and would be a welcome addition to the clinician's armamentarium in the U.S.," said Principal Investigator Dr. David K. Turok, Professor at the University of Utah's Department of Obstetrics and Gynecology.
Innovative Design Features
The new device distinguishes itself through its flexible nitinol frame and reduced copper surface area of 175mm², compared to the 380mm² in current copper IUDs. This design innovation aims to maintain efficacy while potentially improving user experience.
Safety and Tolerability Profile
The study revealed a safety profile consistent with existing IUD options. Key findings include:
- Device expulsion rates of 2.2% at one year and 3.9% at three years
- 15.4% discontinuation rate due to bleeding or pain over three years
- Eight related serious adverse events, including five ectopic pregnancies
- Decreased incidence of bleeding and pain-related adverse events over time
"In addition to the efficacy we saw in this study of the Copper 175mm² IUD, it's promising that bleeding and pain observed in some participants dramatically decreased after the first three months of use," noted Dr. Turok, emphasizing the importance of tolerability in long-acting contraception.
Clinical Significance
Dr. Kelly Culwell, Head of Research and Development at Sebela Women's Health, highlighted the potential impact: "Publication of the results from the Phase 3 study further supports the potential impact this hormone-free IUD option can have for women looking for a non-hormonal, long-acting birth control option."
The American College of Obstetrics and Gynecology (ACOG) recognizes long-acting reversible contraceptive (LARC) methods as among the most effective contraceptive options, with few contraindications and broad patient eligibility.
Ongoing Development
The study continues to evaluate the device's efficacy, safety, and tolerability for up to eight years. Currently under FDA review as part of a New Drug Application, this innovative contraceptive option could expand the range of available non-hormonal birth control methods for women seeking long-term contraception.
