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RECRUITING
NCT05444582
PHASE4

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

Sponsor: University of Utah

View on ClinicalTrials.gov

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

DRUG

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