Recruiting

Levonorgestrel IUD

Sponsor:

University of Utah

Code:

NCT05444582

Conditions

Contraception

Eligibility Criteria

Sex: Female

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Levonorgestrel 52 MG Intrauterine System

Study Details

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

Study ID

NCT05444582

Start date

Nov 7, 2022

Status verified date

Apr, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 35

Healthy Volunteers: Not accepted

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.
  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

1404 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 52 mg LNG IUD Same Day Start or EC

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.

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.

Primary outcome measure

  • Number of pregnancies reported in participants at one month post insertion of IUD [ Time Frame: One Month ]

Central Contacts and Locations

Central contacts

Locations

Planned Parenthood Mar Monte

Recruiting

San Jose, California, United States, 95126

Contacts

Planned Parenthood of the Rocky Mountains

Recruiting

Denver, Colorado, United States, 80207

Contacts

Planned Parenthood Illinoi

Recruiting

Chicago, Illinois, United States, 60603

Contacts

Planned Parenthood League of Massachusetts

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Planned Parenthood Columbia Willamette

Recruiting

Portland, Oregon, United States, 97212

Contacts

Planned Parenthood Association of Utah

Recruiting

Salt Lake City, Utah, United States, 84102

Contacts

Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky

Recruiting

Seattle, Washington, United States, 98122

Contacts

More Information

Sponsor

University of Utah

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Emergency Contraception
  • IUD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-04-16.