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

Recruiting at 7 trial locations

Overseen By Corinne Sexsmith

Age: < 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Utah

Must not be taking: Contraceptives, Estrogen, Progesterone, Testosterone

Disqualifiers: Pregnancy, Breastfeeding, Uterine abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 29

Duration: 4 weeks

1404 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Turok, MD, MPH

Principal Investigator

University of Utah

Eligibility Criteria

Inclusion Criteria

Meet clinic eligibility for IUD placement

Have 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

Negative high sensitivity urine pregnancy test prior to IUD placement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Levonorgestrel 52 mg IUD for emergency contraception or same-day start

4 weeks

1 visit (in-person) for IUD placement

Follow-up

Participants are monitored for safety and effectiveness after IUD placement

4 weeks

Weekly text surveys and a final survey at 28 days

Treatment Details

Interventions

• Levonorgestrel 52 MG Intrauterine System

Participant Groups

Group I: 52 mg LNG IUD Same Day Start or EC Experimental Treatment 1 Intervention

Week 1: Text daily for seven days. Report occurrences of the following in the last day: presence or absence of bleeding, spotting, pain, sexual intercourse, use of other methods of contraception, IUD expulsion or removal, and report any additional medical care received. Weeks 2 \& 3: Weekly text survey assessing on which days of the previous week participants experienced bleeding and spotting, sexual intercourse, use of other methods of contraception, IUD expulsion or removal, or experienced adverse events. Week 4 Survey: At 28 days, participants will be asked about pregnancy symptoms, concern about pregnancy, and the result of their urine pregnancy test including a prompt to upload a photo of the test.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Planned Parenthood Federation of America

Collaborator

Trials

17

Recruited

21,600+