Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start

This protocol builds on our successful execution of the RAPID EC (RCT Assessing Pregnancy with Intrauterine Devices for Emergency Contraception) trial, which demonstrated the LNG 52 mg IUD to be noninferior to the copper IUD for EC. LNG 52 mg IUD users in the study had a one-month EC pregnancy rate of 0.3% (95% CI 0.01-1.7%). Within months of publication of these results in the New England Journal of Medicine, Planned Parenthood Federation of America's (PPFA) National Medical Committee used our data to adopt new contraceptive care guidelines. Today, those presenting for care at any of the over 600+ PPFA health centers in the U.S. can be provided the LNG 52 mg IUD for 2 new situations when they have a negative pregnancy test: 1) EC, within 5 days of unprotected intercourse (UPI) and; 2) Non-EC same-day start, at any point in the menstrual cycle without UPI in the last 5 days. PPFA's clinical application of these data removed an access barrier and will decrease people's risk of undesired pregnancy.

However, the LNG 52 mg IUD prescribing information and Centers for Disease Control and World Health Organization clinical guidelines, which guide clinical care outside of PPFA, currently oppose placement for both of these situations. The current recommendation for those not within the first 7 days of the menstrual cycle is to delay LNG IUD placement and return after the next menses start. We found in the RAPID EC trial and other analyses that the risk of pregnancy appears negligible when initiating an LNG 52 mg IUD for EC or same-day start, provided the urine pregnancy test is negative. This study assesses reproducibility of RAPID EC's findings by determining the effectiveness of the LNG 52 mg IUD to prevent pregnancy in real-world settings where users select their treatment (and are not randomized to it as in RAPID EC trial). We will test reproducibility and generalizability in a larger, more diverse population to assess the appropriateness of defining the interventional IUD as a new standard of care and how PPFA guidelines should be revised before influencing guidelines more broadly.

EC: Pills, the copper IUD, and the importance of adding the LNG 52 mg as a new EC option

Globally, people use EC methods to decrease their risk of pregnancy after UPI because of method failure or not using contraception. EC use in the U.S. is common and increasing. In 2002, 4% of pregnancy capable people ever reporting sexual intercourse had used EC. This figure climbed to 20% by 2015, and to 27% by 2017 for urban women. Although anyone can obtain oral EC without a prescription, IUDs can be desirable for EC because they are much more effective than EC pills and provide ongoing highly effective contraception for years if desired. So, while the majority of EC users do not want an IUD it is an important option with distinct benefits for those that do.

In the U.S., the Food and Drug Administration (FDA) has approved only two methods of EC: oral LNG and oral ulipristal acetate. A third method, the copper IUD, is an evidence-based EC approach and the most effective (failure rate <0.1%), with pregnancy risk an order of magnitude lower than the oral methods. However, those selecting an IUD for long-term contraception are more likely to choose the LNG over the copper IUD. Adding the LNG 52 mg IUD as another EC option, highly effective for both EC and ongoing contraception, is a significant advancement. Especially given that a greater number of contraceptive options presented to an individual is associated with increased method satisfaction, continuation, and decreased unintended pregnancy. The RAPID EC trial demonstrated efficacy for the first new EC method since the 2010 FDA approval of oral ulipristal acetate.