RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Copper; Levonorgestrel

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