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Recruiting Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT05444582

Public ClinicalTrials.gov record NCT05444582. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 7:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a prospective clinical research study to test the effectiveness of the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) for emergency contraception (EC) and same-day start use that will enroll people receiving care at Planned Parenthood affiliates across the U.S. Our prior work demonstrated efficacy (shows that it works in an ideal setting) for the LNG 52 mg IUD for these uses and this study will test effectiveness (how well it works in the real world) in a larger, heterogenous population in a usual care setting where participants select their method and are not randomly assigned to it. The study population will include people initiating an LNG 52 mg IUD and meet inclusion and exclusion criteria at 8 Planned Parenthood affiliates nationwide. Planned Parenthood Federation of America was the first major healthcare organization to change its practice to incorporate the changes we are studying here. As such, all study participants will be offered the opportunity to choose the interventional IUD at the site they visit. The primary outcome is pregnancy status one month after LNG IUD placement by home urine pregnancy test or clinical record review. Participant follow up concludes one month after enrollment. The purpose of this study is to demonstrate reproducibility of earlier findings in a more heterogenous population. As such, IUD placement is not a study procedure but a component of clinical care. The study interventions only involve study participation and provision of data around the use of the levonorgestrel 52 mg IUD for EC or same day start.

Study identification

NCT ID
NCT05444582
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
University of Utah
Other
Enrollment
1,404 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years to 35 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 6, 2022
Primary completion
Mar 30, 2027
Completion
Jul 30, 2027
Last update posted
Apr 15, 2026

2022 – 2027

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
Planned Parenthood Mar Monte San Jose California 95126 Recruiting
Planned Parenthood of the Rocky Mountains Denver Colorado 80207 Recruiting
Planned Parenthood Illinoi Chicago Illinois 60603 Recruiting
Planned Parenthood League of Massachusetts Boston Massachusetts 02215 Recruiting
Planned Parenthood North Central States Saint Paul Minnesota 55114 Active, not recruiting
Planned Parenthood Columbia Willamette Portland Oregon 97212 Recruiting
Planned Parenthood Association of Utah Salt Lake City Utah 84102 Recruiting
Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky Seattle Washington 98122 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05444582, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 15, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05444582 live on ClinicalTrials.gov.

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