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

NCT05444582 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 00151440
• Study Type: interventional
• Target: 1,404
• Locations: 1 country
• Sites: 8

Brief 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

Contraception

Keywords

Emergency Contraception; IUD

Outcome Measures

Primary Outcomes (1)

• Number of pregnancies reported in participants at one month post insertion of IUD

  Positive pregnancies reported by participants through survey and photo of pregnancy test one month after LNG IUD placement by home urine pregnancy test or clinical record review.

  One Month

Secondary Outcomes (1)

• Percentage of participants continuing to use IUD at one month post insertion

  One Month

Study Arms (1)

52 mg LNG IUD Same Day Start or EC

OTHER

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.

Drug: Levonorgestrel 52 MG Intrauterine System

Interventions

Levonorgestrel 52 MG Intrauterine System DRUG

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.

52 mg LNG IUD Same Day Start or EC

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• No known contraindications to the LNG 52 mg IUD per the CDC Medical Eligibility Criteria for Contraceptive Use 2016
• Have had penile-vaginal intercourse at least once since their last menstrual period. If last menstrual period is unknown or irregular, then have had penile-vaginal intercourse at least once in the last month.
• Fluent in English or Spanish
• Working Cell Phone number that receives text messages
• Willing to comply with the study requirements including providing 1-month follow up data including a urine pregnancy test result one month after IUD placement

You may not qualify if:

• Current pregnancy
• Currently Breastfeeding
• Current use of permanent contraception (has had a hysterectomy, tubal permanent contraception, or partner with a vasectomy in the last month)
• Use of any contraceptive pills, patches, vaginal rings or any contraceptive implant or IUD use in the last 4 weeks
• Use of oral emergency contraception in last 5 days
• Vaginal bleeding of unknown etiology
• Use of injectable hormonal contraceptive (Depo-Provera) in the last 6 months
• Planned use of any non-contraceptive estrogen, progesterone, or testosterone
• Acute cervicitis
• Known abnormalities of the uterus that distort the uterine cavity
• Ended pregnancy at or under 20 weeks gestational age within the last 2 weeks
• Ended pregnancy over 20 weeks gestational age within the last 6 weeks

Sponsors & Collaborators

• University of Utah: lead
• Planned Parenthood Federation of America: collaborator

Study Sites (8)

Planned Parenthood Mar Monte

San Jose, California, 95126, United States

RECRUITING

Planned Parenthood of the Rocky Mountains

Denver, Colorado, 80207, United States

RECRUITING

Planned Parenthood Illinoi

Chicago, Illinois, 60603, United States

RECRUITING

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

RECRUITING

Planned Parenthood North Central States

Saint Paul, Minnesota, 55114, United States

ACTIVE NOT RECRUITING

Planned Parenthood Columbia Willamette

Portland, Oregon, 97212, United States

RECRUITING

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

RECRUITING

Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David Turok, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinne Sexsmith

CONTACT

801-213-2522; corinne.sexsmith@hsc.utah.edu

Sarah Elliott, MPH

CONTACT

sarah.elliott@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division Chief of Family Planning, OBGYN

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: November 7, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)