Study of the Copper IUD or Oral Levonorgestrel and the Levonorgestrel IUD for Women Seeking Emergency Contraception

Widely available oral levonorgestrel (LNG) for emergency contraception (EC) has not reduced
unplanned pregnancy rates. However, our study of the copper T380 IUD vs. oral LNG for EC
showed lower pregnancy rates 12 months after presenting for EC in the copper IUD group.
Because there is a strong preference for the LNG IUD among women offered the IUD, the
objective of this research project is to initiate investigation into, and use of the LNG IUD
in the setting of EC. Our experienced team of EC researchers proposes the following aims to
provide needed information in this understudied area:

Aim 1: To assess uptake of the LNG IUD vs. the copper IUD among women presenting for EC
exposed to standardized counseling.

Aim 2: Gather baseline data on one-year continuation and pregnancy rates from women
initiating the LNG IUD vs. the copper T380 IUD when presenting for EC.

Aim 3: Assess willingness of women presenting for EC to participate in a future randomized
controlled trial comparing the LNG IUD vs. the copper T380 IUD for EC.

The study aims will be accomplished with a prospective observational trial of women who
choose either method of EC. The investigative team will recruit 180 women who present for EC
at two participating family planning clinics and follow study participants for 12 months.
This project will compare continuation and pregnancy rates between LNG and copper IUD users
in the year following presentation for EC. This proposal is another aspect in our growing
research program offering highly effective contraception at the time of EC presentation.
Results of this project will direct future study in this area aimed at reducing population
unplanned pregnancy rates among EC users with the potential to inform a future RCT of the
LNG vs. copper IUD for EC.

Inclusion Criteria:1. Between 18-35 years old

2. In need of EC (had unprotected intercourse within 120 hours - 5 days)

3. Desire to prevent pregnancy for 1 year

4. Fluent in English and/or Spanish

5. Have a regular menstrual cycle (24-35 days)

6. Know their last menstrual period (+/-3 days)

7. Be willing to comply with the study requirements

8. Participants current preferred phone number must be functioning at the time of study
entry and will be tested prior to enrollment

Exclusion Criteria:

- 1. Current pregnancy

2. Breastfeeding

3. Intrauterine infection within the past 3 months

4. Sterilization

5. Already have an IUD or contraceptive implant (Implanon) in place

6. Vaginal bleeding of unknown etiology

7. Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully
treated at least 7 days prior to study entry)

8. Allergy to LNG (for LNG IUD patients)

9. Allergy to copper or Wilson's disease (for Copper IUD patients)

10. Known abnormalities of the uterus that distort the uterine cavity