Levonorgestrel Intrauterine System For Emergency Contraception (LIFE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01539720
First received: February 21, 2012
Last updated: December 10, 2014
Last verified: December 2014

February 21, 2012
December 10, 2014
December 2012
July 2016   (final data collection date for primary outcome measure)
Pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The primary outcome of this study is unintended pregnancy following emergency contraception
Same as current
Complete list of historical versions of study NCT01539720 on ClinicalTrials.gov Archive Site
  • LARC use at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Long acting reversible contraception (LARC) use at 6 months following method allocation will be evaluated.
  • Continuation and satisfaction among participants in the LNG-IUS arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Continuation and satisfaction among participants in the LNG-IUS arm
Same as current
Not Provided
Not Provided
 
Levonorgestrel Intrauterine System For Emergency Contraception
Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial

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 method of emergency contraception used in the United States is the oral levonorgestrel regimen which reduces pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine device. The intrauterine device 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 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 levonorgestrel 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 levonorgestrel, 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 survey 6 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 levonorgestrel 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.

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 (EC), or post-coital contraception, offers significant reductions in the chance of pregnancy following an act of unprotected or under-protected vaginal intercourse. Oral emergency contraception is commonly used in the United States is the oral Ulipristal acetate (Ella) regimen which reduces pregnancy risk by 89-95%. More effective, but rarely used, is the Cu T-380 intrauterine device. The intrauterine device 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 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 levonorgestrel IUS as a form of emergency contraception. The purpose of this study is to evaluate the efficacy of the LNG-IUS (levonorgestrel- intrauterine system) as a method of emergency contraception. Participants will be randomized to receive either the most common method, oral levonorgestrel, or the LNG-IUS. Participants will then be called 5-6 weeks following method allocation for results of a self-administered urine pregnancy test. Lastly, participants will be asked to complete telephone surveys 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 levonorgestrel IUS (intrauterine system) 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pregnancy Prevention
  • Emergency Contraception
  • Drug: Ulipristal acetate
    30 mg tablet
    Other Name: Ella
  • Device: levonorgestrel IUS
    Levonorgestrel IUS, 52mg placed intrauterine
    Other Name: Mirena IUD
  • 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.
    Intervention: Device: levonorgestrel IUS
  • 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.
    Intervention: Drug: Ulipristal acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
532
December 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women age 18-45
  • Under-protected intercourse within the last five days (120 hours)
  • Willingness to accept either IUS intervention or oral LNG EC
  • Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)
  • Ability and willingness to be contacted by phone for 6 month follow-up

Exclusion Criteria:

  • Positive pregnancy test
  • Non-English speaking
  • Contraindication to intrauterine contraception or oral LNG EC
  • Inability or unwillingness to comply with follow-up
Female
18 Years to 45 Years
Yes
Contact: Colleen P McNicholas, DO 3147471331 mcnicholasc@wudosis.wustl.edu
Contact: Michele Curran, BS 3147471331 curranm@wudosis.wustl.edu
United States
 
NCT01539720
201201007
Yes
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Not Provided
Washington University School of Medicine
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP