Very few levonorgestrel 52-mg IUD users discontinue IUD due to severe enough hormone-related side effects: Study
Very few levonorgestrel 52-mg IUD users discontinue IUD due to severe enough hormone-related side effects suggests a study published in the American Journal of Obstetrics and Gynecology.
Although the levonorgestrel 52 mg intrauterine device is locally active and has low systemic hormone exposure, hormonal intrauterine device users sometimes report hormone-related side effects. Evaluate hormone-related adverse event rates among all participants and compare these among those who used combined hormonal or no hormonal contraception in the month before enrollment. A total of 1714 women aged 16 to 45 years old received a levonorgestrel 52 mg intrauterine device in a multicenter phase 3 trial to evaluate contraceptive efficacy and safety for up to 10 years.
This analysis evaluated a subset of participants who used combined hormonal or no hormonal contraception in the month prior to device placement. We assessed all nonexpulsion, nonbleeding-related events with ≥1% incidence at 180 days with a plan to include weight increase regardless of incidence; we excluded events considered nonhormonal. We computed 180-day side effect frequency rates based on the number of days a side effect was reported during the study period. We created a multivariable model for side effect incidence at 180 days based on age, race, ethnicity, body mass index at enrollment, parity, and contraception use in the month before enrollment. For those side effects with a P value <.2 on univariate comparison between combined hormonal and no hormonal contraception users, we secondarily evaluated 360-day event rates.
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