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

This study is looking at how well the Levonorgestrel 52 mg Intrauterine System (IUD) works in real-world settings for two purposes: emergency contraception (if you've had unprotected sex in the last 5 days) or as a same-day start birth control method (if it's been more than 7 days since your last period and you haven't had unprotected sex in the last 5 days). You can join if you are a woman between 16 and 35 years old, meet clinic requirements for IUD placement, and have a negative pregnancy test. The study will measure how many participants become pregnant one month after the IUD is put in. This study plans to enroll 1404 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 1404 women. Participants will receive the Levonorgestrel 52 mg IUD.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one month after IUD insertion to check for pregnancies.

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NCT05444582

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

Recruiting
PHASE4Ages 16–35InterventionalTreatment
University of Utah
~1,404 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Levonorgestrel 52 MG Intrauterine System

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of pregnancies reported in participants at one month post insertion of IUD
Measured over One Month
Contraception
8 sites across 8 states
California1
Colorado1
Illinois1
Massachusetts1
Minnesota1
Oregon1
Utah1
Washington1
  • David Turok, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Utah

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Eligibility criteria

Inclusion

Meet clinic eligibility for IUD placement
Have a LNG 52 mg IUD placed for either emergency contraception (had unprotected intercourse in the last 5 days) OR Same-day start, \>7 days since the onset of last menstrual period and have no report of unprotected intercourse in the last 5 days
Negative high sensitivity urine pregnancy test prior to IUD placement.
No known contraindications to the LNG 52 mg IUD per the CDC Medical Eligibility Criteria for Contraceptive Use 2016
Have had penile-vaginal intercourse at least once since their last menstrual period. If last menstrual period is unknown or irregular, then have had penile-vaginal intercourse at least once in the last month.
Fluent in English or Spanish
Working Cell Phone number that receives text messages
Willing to comply with the study requirements including providing 1-month follow up data including a urine pregnancy test result one month after IUD placement

Exclusion

Current pregnancy
Currently Breastfeeding
Current use of permanent contraception (has had a hysterectomy, tubal permanent contraception, or partner with a vasectomy in the last month)
Use of any contraceptive pills, patches, vaginal rings or any contraceptive implant or IUD use in the last 4 weeks
Use of oral emergency contraception in last 5 days
Vaginal bleeding of unknown etiology
Use of injectable hormonal contraceptive (Depo-Provera) in the last 6 months
Planned use of any non-contraceptive estrogen, progesterone, or testosterone
Acute cervicitis
Known abnormalities of the uterus that distort the uterine cavity
Ended pregnancy at or under 20 weeks gestational age within the last 2 weeks
Ended pregnancy over 20 weeks gestational age within the last 6 weeks
  • Number of pregnancies reported in participants at one month post insertion of IUDOne Month

    Positive pregnancies reported by participants through survey and photo of pregnancy test one month after LNG IUD placement by home urine pregnancy test or clinical record review.