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Can an IUD work as emergency contraception? large study aims to find out

NCT ID NCT05444582

Disease control Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing how well the levonorgestrel 52 mg IUD works as emergency contraception and for same-day start in real-world conditions. About 1,400 participants at Planned Parenthood clinics across the U.S. will choose to get the IUD and be followed for one month. The main goal is to see how many pregnancies occur after IUD placement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levonorgestrel 52 mg intrauterine device (IUD)
What this could lead to
If successful, this could confirm that the LNG 52 mg IUD is a highly effective emergency contraception option in real-world settings, expanding access and choice.
What could go wrong
This is a Phase 4 observational study without randomization, so results may be influenced by participant self-selection. The follow-up is only one month, so long-term outcomes are not assessed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,404 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Planned Parenthood Association of Utah

    RECRUITING

    Salt Lake City, Utah, 84102, United States

  • Planned Parenthood Columbia Willamette

    RECRUITING

    Portland, Oregon, 97212, United States

  • Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky

    RECRUITING

    Seattle, Washington, 98122, United States

  • Planned Parenthood Illinoi

    RECRUITING

    Chicago, Illinois, 60603, United States

  • Planned Parenthood League of Massachusetts

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Planned Parenthood Mar Monte

    RECRUITING

    San Jose, California, 95126, United States

  • Planned Parenthood North Central States

    ACTIVE_NOT_RECRUITING

    Saint Paul, Minnesota, 55114, United States

  • Planned Parenthood of the Rocky Mountains

    RECRUITING

    Denver, Colorado, 80207, United States

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