Using Levonorgestrel IUD for Emergency Contraception and Same-Day Start

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 Columbia Willamette
  Portland, Oregon, United States Recruiting
• Planned Parenthood Association of Utah
  Salt Lake City, Utah, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.