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

Emergency Contraception Clinical Trial

— COLIEC  

Official title:

A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963962
• Other study ID #: 50483
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: August 4, 2016
• Start date: July 2013
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. The investigators will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Emergency Contraception

Intervention

Drug:
• Copper IUD

• Levonorgestrel IUD

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Willingness to be randomized to either the copper or levonorgestrel IUD for emergency contraception.	We will query all participants to see if they would be willing to participate in a randomized study where the type of IUD (copper vs. levonorgestrel) was chosen at random.	At enrollment	No
Primary	Pregnancy rates in first month after IUD insertion	Participants will have a urine pregnancy test at the clinic. They will also be given a home urine pregnancy test to check if they are not able to return to clinic and will give results by phone or electronic communication.	4 weeks	Yes
Secondary	1 Year IUD continuation rates	IUD continuation rates will be compared between those who selected the copper IUD and thos who selected the levonorgestrel IUD	1 year	No