NCT01539720|CompletedResultsDMC
Levonorgestrel Intrauterine System For Emergency Contraception
LIFE
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Sponsor study identifier
interventional
274
1 country
3
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 30, 2018
Actual (reported)Study Completion
November 30, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2012
Actual (reported)February 27, 2012
Actual (reported)December 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 30, 2018
Actual (reported)November 30, 2018
Actual (reported)February 20, 2024
Actual (reported)Number of Participants With Pregnancy Following Emergency Contraception
Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.
5 weeks post-randomization
Number of Participants Using Any LARC Method at 6 Months Post Randomization
6 months post randomization
Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS
6 months post randomization
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.
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.
30 mg tablet
Levonorgestrel IUS, 52mg placed intrauterine
Atlanta Women's Center
Atlanta, Georgia, 30342, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63108, United States
Group size limits the precision of our estimate.
Colleen McNicholas, DO, MCSI
Planned Parenthood of the St. Louis Region and Southwest Missouri
274 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2012
First Posted
February 27, 2012
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 30, 2018
Actual (reported)Study Completion
November 30, 2018
Actual (reported)Last Updated
February 20, 2024
Results First Posted
February 20, 2024
Record last verified: 2024-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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