Levonorgestrel Intrauterine System For Emergency Contraception (LIFE)

Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial

The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse.

While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Unplanned; Pregnancy; Accident
• Intervention / Treatment: Device: levonorgestrel IUS; Drug: Ulipristal acetate

Detailed Description

Unintended pregnancy rates in the United States are among the highest of developed nations. These high rates can largely be attributed to incorrect or under contraception of women. One focus of decreasing unintended pregnancy and abortion rates has centered on expanding access to and use of long acting reversible contraceptive (LARC) methods which include intrauterine devices (IUDs) and subdermal implants. Emergency contraception, or post-coital contraception, offers significant reductions in the chance of pregnancy following an act of unprotected or under-protected vaginal intercourse. The most common methods of emergency contraception used in the United States are the oral levonorgestrel regimen and oral ulipristal acetate (Ella) regimen which reduce pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine device (Copper IUD). The IUD has the added benefit of providing extended contraceptive use beyond the single episode of unprotected intercourse. The Cu-T380 has been associated with heavier and more crampy menses however, likely dissuading women from use. Among all IUD users, the levonorgestrel intrauterine system (LNG-IUS) has gained popularity over the Cu-T380, perhaps because it offers the potential to improve menstrual related symptoms. There is no data however on the efficacy of the LNG-IUS as a form of emergency contraception. The purpose of this study is to evaluate the efficacy of the LNG-IUS as a method of emergency contraception. Participants will be randomized to receive either the most common method, oral emergency contraception, or the LNG-IUS. Participants will then be evaluated 5-6 weeks following method allocation for pregnancy. Lastly, participants will be asked to complete a telephone surveys at 6 and 12 months following method allocation assessing their use of a consistent contraceptive method, their satisfaction with their contraceptive method, any use of emergency contraception since their enrollment in the study, and lastly any unintended pregnancies experienced since enrollment in the study. If we could show that the LNG-IUS is as effective as the most commonly prescribed method of emergency contraception, we would be introducing another opportunity for LARC initiation and subsequently impacting unintended pregnancy and abortion rates.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women age 14-45
• Under-protected intercourse within the last five days (120 hours)
• Willingness to accept either intervention: intrauterine contraception or oral emergency contraception (EC)
• Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)
• Ability and willingness to be contacted by phone for 6 and 12 month follow-up

Exclusion Criteria:

• Positive pregnancy test
• Non-English speaking
• Contraindication to intrauterine contraception or oral EC
• Inability or unwillingness to comply with follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levonorgestrel Intrauterine System; Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.	Device: levonorgestrel IUS; Levonorgestrel IUS, 52mg placed intrauterine; Other Names: Liletta; Mirena IUD
Active Comparator: Ulipristal acetate; Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.	Drug: Ulipristal acetate; 30 mg tablet; Other Names: Ella

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Pregnancy Following Emergency Contraception	Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.	5 weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Using Any LARC Method at 6 Months Post Randomization	The number of participants who reported using any type of long acting reversible contraception (LARC) use at 6 months following method allocation will be evaluated, whether or not it was their allocated LNG-IUS.	6 months post randomization
Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS	Continuation and satisfaction among participants in the LNG-IUS arm who reported still using their LNG-IUS at 6 month post randomization.	6 months post randomization

Collaborators and Investigators

• Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri
• Collaborators: University of Colorado, Denver; University of Rochester; Planned Parenthood Federation of America; William and Flora Hewlett Foundation
• Investigators: Principal Investigator: Colleen McNicholas, DO, MCSI, Planned Parenthood of the St. Louis Region and Southwest Missouri

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimated): February 27, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: emergency contraception; Ella; Mirena IUD; post-coital contraception; Liletta IUD
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel; Ulipristal acetate
• Other Study ID Numbers: 201201007