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Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start
Sponsor: University of Utah
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.
Key Details
Gender
FEMALE
Age Range
16 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
1404
Start Date
2022-11-07
Completion Date
2027-07-31
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Levonorgestrel 52 MG Intrauterine System
Eligible participants must be 16-35 years old, meet clinic eligibility for IUD placement, and having 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.
Locations (8)
Planned Parenthood Mar Monte
San Jose, California, United States
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States
Planned Parenthood Illinoi
Chicago, Illinois, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Planned Parenthood North Central States
Saint Paul, Minnesota, United States
Planned Parenthood Columbia Willamette
Portland, Oregon, United States
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States
Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky
Seattle, Washington, United States