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Completed

NCT Number: NCT01539720

Levonorgestrel Intrauterine System For Emergency Contraception

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.

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Key information

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Women's Center, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulipristal Acetate

Drug

30 mg tablet

Other names: Ella

levonorgestrel IUS

Device

Levonorgestrel IUS, 52mg placed intrauterine

Other names: Mirena IUD, Liletta

Primary outcomes

  1. Number of Participants With Pregnancy Following Emergency Contraception

    Time frame: 5 weeks post-randomization

    Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.

Secondary outcomes

  1. Number of Participants Using Any LARC Method at 6 Months Post Randomization

    Time frame: 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.

  2. Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS

    Time frame: 6 months post randomization

    Continuation and satisfaction among participants in the LNG-IUS arm who reported still using their LNG-IUS at 6 month post randomization.

Sponsors and collaborators

Lead sponsor

Planned Parenthood of the St. Louis Region and Southwest Missouri

Other

Collaborators

  • Planned Parenthood Federation of America
  • University of Colorado, Denver
  • University of Rochester
  • William and Flora Hewlett Foundation

Registry information

Official study title

Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial

Acronym: LIFE

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2012
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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