# Levonorgestrel IUD for Emergency Contraception & Same-Day Start Study

> **NIH NIH R01** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2024 · $578,934

## Abstract

PROJECT SUMMARY
This renewal application builds on our successful RAPID EC (RCT Assessing Pregnancy with Intrauterine
Devices for Emergency Contraception) trial, which demonstrated that the levonorgestrel (LNG) 52 mg IUD is
effective for emergency contraception (EC) and noninferior to the copper T380A for EC. In the RAPID EC trial
there was 1 pregnancy among 317 LNG IUD EC users, (pregnancy risk of 0.3%, 95% CI 0-1.7%). We
published the study results in the New England Journal of Medicine, and within months Planned Parenthood
Federation of America’s (PPFA) National Medical Committee used our data to adopt new contraceptive care
guidelines. Today, over 600+ PPFA health centers in the U.S. offer the LNG 52 mg IUD to individuals with a
negative pregnancy test for 2 new situations: a) EC: within 5 days of unprotected intercourse and b) non-EC
same-day start at any point in the menstrual cycle regardless of recent unprotected intercourse. However, the
LNG 52 mg IUD prescribing information and CDC, WHO, and ACOG clinical guidelines, which guide clinical
care outside of PPFA, currently do not recommend placement in either of these 2 new situations. The current
guidelines recommend that those not within the first 7 days of the menstrual cycle and report any unprotected
intercourse (UPI) in the cycle must delay LNG IUD placement and return after the next menses starts. This
creates an access barrier and increases the risk of undesired pregnancy.
Our goal is to assess reproducibility of RAPID EC’s findings by determining the effectiveness of the LNG 52
mg IUD to prevent pregnancy for EC and same-day start in real-world settings where users select their
treatment (and are not randomized to it as in the RAPID EC trial). With guidance from a Reproductive Justice
expert, we will test reproducibility and generalizability in a larger, more diverse population, to assess
whether practice guidelines and standards of care should be revised. To accomplish this we will enroll 1,404
participants at 8 PPFA affiliates with one of three situations where current guidelines limit access but data
support low pregnancy risk. The three groups are: 1) EC regular-cycle group - LNG IUD EC users who have
had UPI within 5 days and have a known last menstrual period and regular menstrual cycles (inclusion criteria
from the RAPID EC trial), 2) Same-day start (not EC) group - people choosing the LNG IUD for contraception
> 7 days after onset of menses without reported UPI within 5 days, 3) EC unknown- or irregular- cycle
group - individuals choosing the LNG IUD for EC without a known last menstrual period or regular menstrual
cycle. All groups will undergo noninferiority comparisons. Group 1 will be compared to the historical data from
the LNG IUD participants in the RAPID EC trial. Group 2 and 3 will be compared to group 1. For all groups we
expect one-month pregnancy rates <1%. Rigorous, reproducible, and generalizable data on LNG 52 mg IUD
use for EC or same-day start from more het...

## Key facts

- **NIH application ID:** 10912019
- **Project number:** 5R01HD083340-07
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** David Turok
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $578,934
- **Award type:** 5
- **Project period:** 2015-07-27 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10912019

## Citation

> US National Institutes of Health, RePORTER application 10912019, Levonorgestrel IUD for Emergency Contraception & Same-Day Start Study (5R01HD083340-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10912019. Licensed CC0.

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