Levonorgestrel IUD Effective as Emergency Contraception

Jake Remaly

February 05, 2021

A levonorgestrel 52-mg intrauterine device (IUD) is noninferior to a copper IUD for emergency contraception, according to randomized trial results published online in The New England Journal of Medicine.

Although the trial didn't directly compare emergency oral contraception to the hormonal IUD, the authors speculate, on the basis of prior findings, that the levonorgestrel IUD is more effective than oral emergency contraceptive pills. In addition, there is no delay in providing ongoing contraception as there is when ulipristal acetate is used for emergency contraception.

Prior research has found that copper IUDs are a highly effective method of emergency contraception, but studies of the use of other IUDs as emergency contraception have been lacking.

To examine whether the levonorgestrel IUD is noninferior to the copper IUD as emergency contraception after unprotected sexual intercourse during the previous 5 days, David K. Turok, MD, MPH, associate professor of obstetrics and gynecology at the University of Utah Health, Salt Lake City, Utah, and colleagues conducted a trial at six Planned Parenthood health centers in Utah.

Researchers enrolled patients between August 2016 and December 2019. Trial sites purchased levonorgestrel 52-mg IUDs (Liletta) and copper T380A IUDs (ParaGard) for the study. The companies that distribute the IUDs were not involved in the trial.

Pregnancy rates were 1 of 317 participants (0.3%) among those who received the levonorgestrel IUD, and 0 of 321 (0%) among those who received the copper IUD. The difference between the two arms was well within the prespecified noninferiority margin of 2.5%.

Adverse event rates were generally similar between the two groups, with 5.2% of participants in the levonorgestrel IUD group seeking medical care in the month after IUD placement compared with 4.9% in the copper IUD group.

A Welcome Option

The study "benefits women by allowing us to introduce a new option into the method mix of emergency contraception," commented Wing Kay Fok, MD, a clinical assistant professor of obstetrics and gynecology at Weill Cornell Medicine in New York City.

Specialists in family planning had followed preliminary data from this study and were anticipating the final results. Clinicians who are comfortable placing a copper IUD for emergency contraception are likely to be comfortable placing a levonorgestrel 52-mg IUD, given these data, Fok said.

"This is definitely — from what we can tell — a more effective method than the pill," she said.

Gabriela Aguilar, MD, MPH, fellow and clinical instructor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine in New Haven, Connecticut, said she is reassured by the data and is prepared to offer the 52-mg levonorgestrel IUD as emergency contraception.

The trial is "an important clinical study that has the ability to significantly change clinical practice," Aguilar said. She credited the University of Utah and Planned Parenthood for their roles in it.

"Anytime that there are more options, ideally, that means that access is also increased," Aguilar said.

Many patients will still prefer oral emergency contraceptive pills, she said. "But for those who are interested in an IUD...for the immediate and ongoing birth control after that, now they have the two options instead of just the one IUD option," she said.

One Pregnancy

The trial included women aged 18 to 35 years who requested emergency contraception after unprotected sexual intercourse within the previous 5 days. Other inclusion criteria were that participants had a desire to initiate use of an IUD; a desire to prevent pregnancy for at least 1 year; a negative result on urine pregnancy testing; a history of regular menstrual cycles; and a known date of the last menstrual period. The investigators did not exclude individuals who had had unprotected sexual intercourse more than 5 days before IUD placement.

Participants were unaware of their assigned intervention. The nurse practitioners and certified nurse midwives who performed the IUD insertions were aware of the IUD type.

The primary outcome was pregnancy, as determined by a positive result on urine pregnancy testing 1 month after IUD insertion or by a review of survey and health record data.

One pregnancy "occurred in a participant who reported a single episode of unprotected sexual intercourse 48 hours before IUD placement," the study authors write. "Pregnancy dating by an ultrasound examination at 10 weeks was consistent with conception occurring as a result of an emergency contraception failure. The pregnancy ended in a spontaneous abortion at 10 weeks with the IUD still in place."

"We hope that providers can begin to deliver this method to everyone who wants and needs it and that people considering both emergency contraception and an ongoing method of birth control know that they now have the option of a hormonal IUD in addition to the nonhormonal, copper IUD," Turok said in a news release from Planned Parenthood.

The study used a hormonal IUD manufactured by Liletta; Mirena also manufactures a levonorgestrel 52-mg IUD. The results of the study would apply to Mirena's product too, according to Planned Parenthood.

"There are various IUDs on the market that are at lower doses, and so those IUDs may not demonstrate similar results," Aguilar said.

The research was supported by the National Institutes of Health and the University of Utah. Turok is the director of surgical services for Planned Parenthood Association of Utah (PPAU). The trial was conducted at PPAU centers, but Turok does not work at the sites where the study was conducted. Turok has consulted for Sebela Pharmaceuticals as the principal investigator for two phase 3 studies that assessed novel IUDs. Turok and coauthor Gawron has received grant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Fok and Aguilar have disclosed no relevant financial relationships.

N Engl J Med. Published online January 28, 2021. Abstract

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