NCT05444582 · University of Utah
Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start
What this study is about
This is a forward-looking 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.
View original scientific description
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.
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.
Primary outcome measures
Number of pregnancies reported in participants at one month post insertion of IUD
Time frame: One Month
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 pregn
Where
- San Jose, California
- Denver, Colorado
- Chicago, Illinois
- Boston, Massachusetts
- Saint Paul, Minnesota
- Portland, Oregon
- Salt Lake City, Utah
- Seattle, Washington
Collaborators
Planned Parenthood Federation of America
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations