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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

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Copper IUD Drug: Levonorgestrel IUD Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Active Comparator: Copper T380 IUD
Randomized to copper T380 IUD for EC (emergency contraception)
Drug: Copper IUD
Randomization to copper/Paragard IUD for emergency contraception
Other Name: Paragard IUD

Active Comparator: LNG20 IUD
Randomized to LNG20 IUD for EC (emergency contraception)
Drug: Levonorgestrel IUD
Randomization to Levonorgestrel/Mirena IUD for emergency contraception
Other Name: Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175030


Contacts
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Contact: Marie Gibson 801-213-2845 marie.gibson@hsc.utah.edu
Contact: Jessica Sanders, PhD 801-581-6170 jessica.sanders@hsc.utah.edu

Locations
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United States, Utah
Planned Parenthood Association of Utah Recruiting
West Valley City, Utah, United States, 84119
Contact: Marie Gibson    801-213-2845    marie.gibson@hsc.utah.edu   
Contact: Jessica Sanders, PhD    801-581-6170    jessica.sanders@hsc.utah.edu   
Principal Investigator: David K Turok, MD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: David Turok, MD University of Utah

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Responsible Party: David Turok, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT02175030     History of Changes
Other Study ID Numbers: 73554
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Turok, University of Utah:
Emergency contraception
Levonorgestrel IUD
Copper IUD

Additional relevant MeSH terms:
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Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Nutrients
Growth Substances