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Trial record 6 of 396 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT01963962
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah

Tracking Information
First Submitted Date October 11, 2013
First Posted Date October 17, 2013
Last Update Posted Date August 8, 2016
Study Start Date July 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01963962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 11, 2013)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 11, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Study of the Copper IUD or Oral Levonorgestrel and the Levonorgestrel IUD for Women Seeking Emergency Contraception
Official Title A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception
Brief 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine to test for progesterone and/or pregnandiol
Sampling Method Non-Probability Sample
Study Population Women presenting for emergency contraception to family planning clinics in Salt Lake City, UT
Condition Emergency Contraception
Intervention
  • Drug: Copper IUD
    Other Name: Paragard IUD
  • Drug: Levonorgestrel IUD
    Other Name: Mirena IUD
Study Groups/Cohorts
  • Copper IUD
    Women selecting the copper IUD for emergency contraception and to use for contraception after
    Intervention: Drug: Copper IUD
  • Levonorgestrel IUD
    Women who select oral levonorgestrel for emergency contraception and begin the levonorgestrel IUD for ongoing contraception at the same time.
    Intervention: Drug: Levonorgestrel IUD
Publications * Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016 Jun;93(6):526-32. doi: 10.1016/j.contraception.2016.01.009. Epub 2016 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2016)
188
Original Estimated Enrollment
 (submitted: October 11, 2013)
180
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01963962
Other Study ID Numbers 50483
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David Turok, University of Utah
Study Sponsor University of Utah
Collaborators Not Provided
Investigators
Principal Investigator: David Turok, MD University of Utah
PRS Account University of Utah
Verification Date August 2016