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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

711

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2016

Longer than P75 for phase_4

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

June 23, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed

2.1 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

June 29, 2022

Completed

Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

3.5 years

First QC Date

June 23, 2014

Results QC Date

March 31, 2022

Last Update Submit

June 27, 2022

Conditions

Contraception

Keywords

Emergency contraceptionLevonorgestrel IUDCopper IUD

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Reporting a Pregnancy
Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic. We will use the total number of pregnancies per ARM and the overall number of participants analyzed per ARM to calculate, for each ARM, the percentage of participants reporting a pregnancy in the first month of use of the IUD.
1 month after enrollment

Secondary Outcomes (1)

Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.
1 year after enrollment

Study Arms (2)

Copper T380 IUD

ACTIVE COMPARATOR

Randomized to copper T380 IUD for EC (emergency contraception)

Drug: Copper IUD

LNG20 IUD

ACTIVE COMPARATOR

Randomized to LNG20 IUD for EC (emergency contraception)

Drug: Levonorgestrel IUD

Interventions

Copper IUDDRUG

Randomization to copper/Paragard IUD for emergency contraception

Also known as: Paragard IUD

Copper T380 IUD

Levonorgestrel IUDDRUG

Randomization to Levonorgestrel/Mirena IUD for emergency contraception

Also known as: Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD

LNG20 IUD

Eligibility Criteria

Age18 Years - 35 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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 (21-35 days)
Know their last menstrual period (+/-3 days)
Be willing to comply with the study requirements
Desire to initiate an IUD
Negative urine pregnancy test

You may not qualify if:

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
Allergy to copper
Use of oral Emergency Contraception in the preceeding 5 days

Contact the study team to confirm eligibility.