Novel copper IUD proves safe, effective during first year of phase 3 trial
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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.
Perspective
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Sarah Horvath, MD, MSHP
There are many copper IUDs used throughout Europe. In the U.S., we currently only have one FDA-approved nonhormonal IUD, so it is great to see a new one being studied for potential use here in the U.S. I particularly appreciate the inclusion of large numbers of nulliparous participants. I routinely offer all contraceptive methods to people who have never had children, but some folks don’t like to do that, so including them in the initial studies is important for patient access.
The pregnancy rates, adverse events and discontinuation rates are on a par with other IUDs, so this seems like a device that patients might use. I’d like to know how the bleeding profile compares to what the participants experienced before using the IUD. The most common reason I get from patients for not choosing the current copper IUD is that they don’t want to risk having more bleeding or cramping, which happens in about 20% of patients. If that is not the case with this IUD, it would be a real advantage. I’d like to know how long this IUD might be effective, as well.
There is no one perfect contraceptive method. If there were, we wouldn't have so many of them! This study presents a new IUD that is nonhormonal, safe and effective. There is a niche patient population seeking this type of contraception, and I am hopeful that this may help them in the future.
Department of obstetrics and gynecology
Penn State College of Medicine
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