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RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

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ClinicalTrials.gov Identifier: NCT02175030
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah

Tracking Information
First Submitted Date  ICMJE June 23, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
Determine the efficacy of the levonorgestrel IUD and copper T380 IUD for emergency contraception as assessed by urine pregnancy tests 1 month after EC use. [ Time Frame: 1 month after enrollment ]
Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
Determine the efficacy of the levonorgestrel IUD and copper T380 IUD for emergency contraception as assessed by urine pregnancy tests 7 days after the expected onset of the next menses. [ Time Frame: 1 month after enrollment ]
Urine pregnancy tests 7 days after the expected onset of the next menses will be performed either at home or in clinic.
Change History Complete list of historical versions of study NCT02175030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
Compare the one-year unintended pregnancy rates from women initiating the levonorgestrel IUD vs. copper T380 IUD for EC. [ Time Frame: 1 year after enrollment ]
Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
Compare the one-year unintended pregnancy rates from women initiating the levonorgestrel IUD vs. copper T380 IUD for EC. [ Time Frame: 1 year after enollment ]
Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
Official Title  ICMJE RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception
Brief Summary This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. This research has the potential to increase use of highly effective contraception in a high-risk population and lower the persistently elevated rate of U.S. unintended pregnancy.
Detailed Description

Unintended pregnancy has multiple adverse effects on both maternal and child health. The United States continues to have one of the highest rates of unintended pregnancy among developed countries. To combat this problem, we are studying initiation of the highly effective intrauterine device (IUD) for women presenting for emergency contraception (EC). This is an ideal population to initiate highly effective reversible contraception (HERC) as they are at high risk of unintended pregnancy and are acting to reduce that risk. We have recently demonstrated significantly lower pregnancy rates 12 months after presenting for EC among women who selected the copper IUD versus those who selected oral Levonorgestrel (LNG).

Not only is the copper IUD the most effective method of EC, it is considered a top tier anticipatory contraception method and its ability to prevent pregnancy is on par with tubal sterilization (less than 1% in the first year with lower failure rates in subsequent years). However, women selecting intrauterine contraception have shown a strong preference for the LNG IUD. The LNG IUD, is as effective at preventing pregnancy as the Copper IUD, and has some non-contraceptive effects that many women see as benefits such as the reduction or elimination of menstrual bleeding and menstrual related discomfort. Of currently available reversible contraceptives, the LNG IUD has the highest levels of user satisfaction and continuation. However, its effectiveness as an emergency contraceptive remains unknown. A randomized control trial is necessary to assess the safety and efficacy of the LNG IUD as EC. Demonstrating the efficacy, safety, and acceptability of the LNG IUD for EC will improve options for women seeking EC and who desire a highly effective method of contraception.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: Copper IUD
    Randomization to copper/Paragard IUD for emergency contraception
    Other Name: Paragard IUD
  • Drug: Levonorgestrel IUD
    Randomization to Levonorgestrel/Mirena IUD for emergency contraception
    Other Name: Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD
Study Arms  ICMJE
  • Active Comparator: Copper T380 IUD
    Randomized to copper T380 IUD for EC (emergency contraception)
    Intervention: Drug: Copper IUD
  • Active Comparator: LNG20 IUD
    Randomized to LNG20 IUD for EC (emergency contraception)
    Intervention: Drug: Levonorgestrel IUD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2016)
706
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2014)
777
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females between 18-35 years old
  • In need of EC (had unprotected intercourse within 120 hours - 5 days)
  • Desire to prevent pregnancy for 1 year
  • Fluent in English and/or Spanish
  • Have a regular menstrual cycle (24-35 days)
  • Know their last menstrual period (+/-3 days)
  • Be willing to comply with the study requirements
  • Participants current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment

Exclusion Criteria:

  • Current pregnancy
  • Breastfeeding
  • Intrauterine infection within the past three months
  • Sterilization
  • Already have an IUD or contraception implant (Nexplanon) in place
  • Vaginal bleeding of unknown etiology
  • Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)
  • Known abnormalities of the uterus that distort the uterine cavity
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Gibson 801-213-2845 marie.gibson@hsc.utah.edu
Contact: Jessica Sanders, PhD 801-581-6170 jessica.sanders@hsc.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02175030
Other Study ID Numbers  ICMJE 73554
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Turok, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Turok, MD University of Utah
PRS Account University of Utah
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP