Levonorgestrel Intrauterine System For Emergency Contraception
Condition: Pregnancy, Unplanned; Pregnancy; Accident
MeSH terms: Emergencies
Study type: Interventional

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.
    

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.
    

Intervention name(s): Ulipristal acetate; levonorgestrel IUS
Intervention type(s): Drug; Device
Intervention description(s): 30 mg tablet; Levonorgestrel IUS, 52mg placed intrauterine
Other intervention name(s): Ella; Mirena IUD; Liletta
Intervention MeSH terms: Levonorgestrel; Ulipristal acetate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: emergency contraception; Ella; Mirena IUD; post-coital contraception; Liletta IUD