Phase 4 N=711 Randomized Prevention

RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT02175030 ↗

Enrolled (actual)

711

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Percentage of Participants Reporting a Pregnancy — 0; 0.3 % of participants reporting pregnancy

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Copper IUD (Drug); Levonorgestrel IUD (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Utah
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Reporting a Pregnancy	0; 0.3	—
SECONDARY Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.	7; 7	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02175030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.