Condition: Contraception · Sponsor: University of Utah
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…
This description comes directly from the study's public registry record.
Corinne Sexsmith · 801-213-2522 · corinne.sexsmith@hsc.utah.edu
Sarah Elliott, MPH · sarah.elliott@hsc.utah.edu
Always discuss trial participation with your own doctor first.
| Planned Parenthood Mar Monte | San Jose, California, United States | Recruiting |
| Planned Parenthood of the Rocky Mountains | Denver, Colorado, United States | Recruiting |
| Planned Parenthood Illinoi | Chicago, Illinois, United States | Recruiting |
| Planned Parenthood League of Massachusetts | Boston, Massachusetts, United States | Recruiting |
| Planned Parenthood North Central States | Saint Paul, Minnesota, United States | Active Not Recruiting |
| Planned Parenthood Columbia Willamette | Portland, Oregon, United States | Recruiting |
| Planned Parenthood Association of Utah | Salt Lake City, Utah, United States | Recruiting |
| Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky | Seattle, Washington, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05444582