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RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Copper IUD (Drug); Levonorgestrel IUD (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
David Turok, MD, Principal Investigator, Affiliation: University of Utah

Overall contact:
Jessie Barlow, Phone: 801-937-9675, Email: research@ppau.org

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.

Clinical Details

Official title: RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome: Compare the one-year unintended pregnancy rates from women initiating the levonorgestrel IUD vs. copper T380 IUD for EC.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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 (Implanon) 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)

Locations and Contacts

Jessie Barlow, Phone: 801-937-9675, Email: research@ppau.org

Planned Parenthood Association of Utah, West Valley City, Utah 84119, United States; Not yet recruiting
Jessie Barlow, Phone: 801-973-9675, Email: research@ppau.org
David K Turok, MD, Principal Investigator
Additional Information

Starting date: September 2015
Last updated: July 15, 2015

Page last updated: August 23, 2015

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