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

August 4, 2016 updated by: David Turok, University of Utah

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Planned Parenthood Association of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women presenting for emergency contraception to family planning clinics in Salt Lake City, UT

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Copper IUD
Women selecting the copper IUD for emergency contraception and to use for contraception after
Drug: Copper IUD
Other Names:
  • Paragard IUD
Levonorgestrel IUD
Women who select oral levonorgestrel for emergency contraception and begin the levonorgestrel IUD for ongoing contraception at the same time.
Drug: Levonorgestrel IUD
Other Names:
  • Mirena IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rates in first month after IUD insertion
Time Frame: 4 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 Year IUD continuation rates
Time Frame: 1 year
IUD continuation rates will be compared between those who selected the copper IUD and thos who selected the levonorgestrel IUD
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to be randomized to either the copper or levonorgestrel IUD for emergency contraception.
Time Frame: At enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (ESTIMATE)

October 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50483

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Emergency Contraception

Clinical Trials on Copper IUD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe