Copper IUDs Do Not Cause Significant Changes in Serum Copper: Presented at ASRM

By Louise Gagnon

VIRTUAL -- October 22, 2021 -- Women who used either a novel low-dose nitinol frame copper intrauterine device (IUD) or a standard-dose copper IUD (T380A, Paragard) were not exposed to abnormal serum copper concentrations, according to a study presented at the 2021 Annual Meeting of the American Society for Reproductive Medicine (ASRM).

“Serum copper concentrations for the 2 IUDs remained within the normal range and trended toward lower values for participants assigned to the low-dose copper IUD relative to the T380A,” said Jeffrey Jensen, MD, Oregon Health & Science University, Portland, Oregon. “Neither IUD generated clinically meaningful changes in total serum copper concentrations during the first 56 days after IUD placement. These data can assure clinicians and copper IUD users of the safety of these IUDs regarding copper exposure and systemic uptake.”

The researchers analysed serum copper in women who were randomised to receive either a novel low-dose nitinol frame copper IUD, with 175 mm2 of exposed copper n = 19), or the copper T380A IUD, with 380 mm2 of exposed copper (n = 17), through the first 57 days of use.

Participants provided 2 baseline total serum copper samples at least 24 hours apart within 28 days prior to IUD placement followed by 7 samples following randomisation on days 1, 3, 8, 15, 22, 29, and 57.

The baseline mean serum copper concentrations for the low-dose group were 1,220 ng/ml ± 285 ng/ml versus 1,250 ng/ml ± 276 ng/ml for the T380A group. Observed copper concentrations in both groups remained in the normal range (490-1,840 ng/ml) up to 56 days.

Post IUD placement values for both the low-dose group and the copper T380A group were slightly lower than baseline values over the 7 timepoints from 0-56 days. Respective baseline-corrected mean values for the low-dose group were 7.8 to 29.8 ng/ml and for the T380A group were 14.9 to 34.3 ng/ml lower than baseline.

“There were small but measurable increases in serum copper that remained well within the standard deviation to the baseline values,” said Dr. Jensen. “While levels for the low-dose IUD were marginally lower, about 6%, this is not likely to be clinically important. Since copper release decreases slowly over time, these data are reassuring regarding safety of exposure.”

Funding for this study was provided by Sebela Pharmaceuticals.

[Presentation title: Comparative Copper Pharmacokinetic Properties of a Novel Low-Dose Nitinol Frame Copper Intrauterine Device (IUD) and the Copper T380A IUD: a Randomized, Controlled Trial. Abstract 434]

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