Levonorgestrel Intrauterine System For Emergency Contraception (LIFE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01539720
First received: February 21, 2012
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Pregnancy Prevention
Emergency Contraception
Drug: oral levonorgestrel
Device: levonorgestrel IUS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The primary outcome of this study is unintended pregnancy following emergency contraception


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 532
Study Start Date: February 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levonorgestrel Intrauterine System
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up for urine pregnancy test and string check 5-6 weeks following
Device: levonorgestrel IUS
Levonorgestrel IUS, 52mg placed intrauterine
Other Name: Mirena IUD
Active Comparator: Oral Levonorgestrel
Women in this arm will receive the oral levonorgestrel regimen, which is currently the most commonly used method.
Drug: oral levonorgestrel
1.5mg levonorgestrel PO once
Other Name: Plan B, Next Choice

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539720

Contacts
Contact: Colleen P McNicholas, DO 3147471331 mcnicholasc@wudosis.wustl.edu
Contact: Meghan proehl 3147471331 proehlm@wudosis.wustl.edu

Locations
United States, Missouri
Washington University in St Louis Recruiting
St Louis, Missouri, United States, 63110
Contact: Meghan Proehl       proehlm@wudosis.wustl.edu   
Principal Investigator: Colleen P McNicholas, DO         
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01539720     History of Changes
Other Study ID Numbers: 201201007
Study First Received: February 21, 2012
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
emergency contraception
Plan B
Mirena IUD
post-coital contraception

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014