Levonorgestrel Intrauterine System For Emergency Contraception (LIFE)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy, Unplanned; Pregnancy; Accident	Drug: Ulipristal acetate; Device: levonorgestrel IUS	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	532 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial
Study Start Date :	December 2012
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Mirena IUD; Liletta
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 Name: Ella

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pregnancy [ Time Frame: 6 weeks ]
   The primary outcome of this study is unintended pregnancy following emergency contraception

Secondary Outcome Measures :

1. LARC use at 6 and 12 months [ Time Frame: 12 months ]
   Long acting reversible contraception (LARC) use at 6 months following method allocation will be evaluated.
2. Continuation and satisfaction among participants in the LNG-IUS arm [ Time Frame: 12 months ]
   Continuation and satisfaction among participants in the LNG-IUS arm

Eligibility Criteria

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Ages Eligible for Study:	14 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Colleen P McNicholas, DO	314-747-1425	mcnicholasc@wustl.edu
Contact: Loire Biggs, BA	314-747-1425	loirebiggs@wustl.edu

Locations

United States, Missouri
Washington University in St Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Loire Biggs, BA 314-747-1425 loirebiggs@wustl.edu
Principal Investigator: Colleen P McNicholas, DO

Sponsors and Collaborators

Washington University School of Medicine

William and Flora Hewlett Foundation

University of Colorado, Denver

Planned Parenthood Federation of America

University of Rochester

Investigators

Principal Investigator:	Colleen P McNicholas, DO	Washington University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01539720 History of Changes
Other Study ID Numbers:	201201007
First Posted:	February 27, 2012
Last Update Posted:	January 30, 2018
Last Verified:	January 2018

Keywords provided by Washington University School of Medicine:

emergency contraception; Ella; Mirena IUD; post-coital contraception; Liletta IUD

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes; Levonorgestrel; Contraceptive Agents, Female	Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral, Synthetic; Contraceptives, Oral