Using Levonorgestrel IUD for Emergency Contraception and Same-Day Start
Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start
This study is testing if the Levonorgestrel IUD can be an effective option for emergency contraception when people start using it on the same day.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1404 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | Female |
| Sponsor | University of Utah Academic / other |
| Locations | 8 sites (San Jose, California and 7 other locations) |
| Trial ID | NCT05444582 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the effectiveness of the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) for emergency contraception and same-day initiation in a real-world setting. Participants will be enrolled from various Planned Parenthood affiliates across the U.S. and will have the option to choose the LNG IUD based on their individual circumstances. The study aims to confirm previous findings that demonstrated the LNG IUD's efficacy in preventing pregnancy when used in these contexts, while also addressing current clinical guidelines that may restrict its use. By assessing a diverse population, the study seeks to provide insights into the practical application of this contraceptive method.
Who should consider this trial
Good fit: Ideal candidates include individuals seeking emergency contraception or those who wish to start using an IUD outside of their menstrual cycle.
Not a fit: Patients who are currently pregnant or have contraindications to the LNG IUD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance access to effective emergency contraception and same-day IUD placement, reducing the risk of unintended pregnancies.
How similar studies have performed: Previous studies have shown success with similar approaches, particularly the RAPID EC trial, which established the LNG IUD's efficacy for emergency contraception.
Eligibility criteria
Show full inclusion / exclusion 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. * 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
Where this trial is running
San Jose, California and 7 other locations
- Planned Parenthood Mar Monte — San Jose, California, United States (Recruiting)
- Planned Parenthood of the Rocky Mountains — Denver, Colorado, United States (Recruiting)
- Planned Parenthood Illinoi — Chicago, Illinois, United States (Recruiting)
- Planned Parenthood League of Massachusetts — Boston, Massachusetts, United States (Recruiting)
- Planned Parenthood North Central States — Saint Paul, Minnesota, United States (Active_not_recruiting)
- Planned Parenthood Columbia Willamette — Portland, Oregon, United States (Recruiting)
- Planned Parenthood Association of Utah — Salt Lake City, Utah, United States (Recruiting)
- Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: David Turok, MD, MPH — University of Utah
- Study coordinator: Corinne Sexsmith
- Email: corinne.sexsmith@hsc.utah.edu
- Phone: 801-213-2522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.