Novel copper IUD proves safe, effective during first year of phase 3 trial
A copper intrauterine device, or IUD, with a novel design was safe, effective and well-tolerated in women during the first year of use, according to results from a phase 3 clinical trial.
Researchers noted that copper IUDs represent the only highly effective, hormone-free, reversible contraception option approved by the FDA for women in the United States, and they have not undergone a significant design change in the last 35 years. The IUD they are currently studying, developed by Sebela Pharmaceuticals, is a low-dose model that includes several design advantages, they said.
“The frame of this copper IUD, with less copper than currently available copper IUDs, is flexible with the idea that, with normal uterine contractions, the frame will be more compliant and not result in cramping to the extent that some copper IUD users experience,” Mitchell D. Creinin, MD, a professor of obstetrics and gynecology at the University of California, Davis, told Healio Primary Care. “Also, because the nickel titanium frame has a ‘forever’ memory, the IUD can be pre-loaded in a very narrow inserter to make insertion easier for the clinician and patient. Strings are pre-cut, which also removes a step in the insertion process, further simplifying insertion.”
At the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting, the researchers reported results from 1,619 women aged 36 to 45 years who used the device for a year — part of a 5-year clinical trial to gain FDA approval that is being conducted at 42 U.S. sites.
The primary endpoint for this report was the contraceptive effectiveness over 1 year, which was measured using the Pearl Index, and secondary outcomes included placement success, safety, expulsion, bleeding outcomes, adverse events and whether women continued with the study past the first year.
The researchers identified nine pregnancies during the first year, including two ectopic pregnancies (Pearl Index = 0.93 [95% CI, 0.43-1.77]). The IUD was successfully placed on the first attempt in 96.3% of participants. There were two perforations (0.1%) and 36 expulsions (2.3%). The mean number of days with bleeding and spotting per 28-day cycle decreased from 11.2 in the first cycle to 7.7 in the third, after which point it leveled off and remained stable for the remainder of the year, according to Creinin. About 14% of participants discontinued use of the IUD because of adverse events, but more than a quarter (77.4%) continued with the study beyond year 1.
According to Creinin, the last participant is expected to complete the study in late 2024.
“These data represent the first-year outcomes in this pivotal phase 3 study,” he said.