CompletedPhase 4

RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

United States711 participantsStarted 2016-08

Plain-language summary

This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. This research has the potential to increase use of highly effective contraception in a high-risk population and lower the persistently elevated rate of U.S. unintended pregnancy.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Females between 18-35 years old * In need of EC (had unprotected intercourse within 120 hours - 5 days) * Desire to prevent pregnancy for 1 year * Fluent in English and/or Spanish * Have a regular menstrual cycle (21-35 days) * Know their last menstrual period (+/-3 days) * Be willing to comply with the study requirements * Desire to initiate an IUD * Negative urine pregnancy test Exclusion Criteria: * Current pregnancy * Breastfeeding * Intrauterine infection within the past three months * Sterilization * Already have an IUD or contraception implant (Nexplanon) in place * Vaginal bleeding of unknown etiology * Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry) * Known abnormalities of the uterus that distort the uterine cavity * Allergy to copper * Use of oral Emergency Contraception in the preceeding 5 days

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Reporting a Pregnancy

Timeframe: 1 month after enrollment

Trial details

NCT IDNCT02175030

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02

Results submitted2022-03-31

View on ClinicalTrials.gov More Contraception trials