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Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start
NCT05444582 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Levonorgestrel 52 MG Intrauterine System
Study Locations (8)
California
- Planned Parenthood Mar Monte — San Jose
Colorado
- Planned Parenthood of the Rocky Mountains — Denver
Illinois
- Planned Parenthood Illinoi — Chicago
Massachusetts
- Planned Parenthood League of Massachusetts — Boston
Minnesota
- Planned Parenthood North Central States — Saint Paul
Oregon
- Planned Parenthood Columbia Willamette — Portland
Utah
- Planned Parenthood Association of Utah — Salt Lake City
Washington
- Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,404 participants |
| Start Date | 2022-11-07 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05444582
The ClinicalTrials.gov registry entry for NCT05444582 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,404 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 686 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention — of which Levonorgestrel 52 MG Intrauterine System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05444582 reports 8 study locations spanning 8 distinct geographic areas — top geographies include California, Colorado, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05444582 about?
NCT05444582 is a clinical study titled "Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start". 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 demonstra...
What is the current status of trial NCT05444582?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,404 participants. The study started on 2022-11-07. Estimated completion is 2027-07-31.
What conditions does trial NCT05444582 study?
This clinical trial studies the following conditions: Contraception. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05444582?
The interventions under investigation include: Levonorgestrel 52 MG Intrauterine System (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05444582?
This trial is sponsored by University of Utah, which has 686 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05444582 being conducted?
This trial has 8 study locations across California, Colorado, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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