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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01963962
First received: October 11, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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. We will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.


Condition Intervention
Emergency Contraception
Drug: Copper IUD
Drug: Levonorgestrel IUD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Pregnancy rates in first month after IUD insertion [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 1 Year IUD continuation rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    IUD continuation rates will be compared between those who selected the copper IUD and thos who selected the levonorgestrel IUD


Other Outcome Measures:
  • Willingness to be randomized to either the copper or levonorgestrel IUD for emergency contraception. [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Urine to test for progesterone and/or pregnandiol


Estimated Enrollment: 180
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Copper IUD
Women selecting the copper IUD for emergency contraception and to use for contraception after
Drug: Copper IUD
Other Name: 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 Name: Mirena IUD

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. We will recruit 180 women who present for EC at two participating family planning clinics and follow study participants for 12 months. We 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963962

Contacts
Contact: Ryanne Neville 801-637-6307 research@PPAU.ORG

Locations
United States, Utah
Planned Parenthood Association of Utah Recruiting
Salt Lake City, Utah, United States, 84102
Principal Investigator: David Turok, MD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: David Turok, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01963962     History of Changes
Other Study ID Numbers: 50483
Study First Received: October 11, 2013
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Emergency contraception
Levonorgestrel IUD
Copper IUD
Oral Levonorgestrel

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Copper
Levonorgestrel
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 29, 2014