Levonorgestrel Intrauterine System For Emergency Contraception (LIFE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01539720|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : June 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy, Unplanned Pregnancy; Accident||Drug: Ulipristal acetate Device: levonorgestrel IUS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||273 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
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.
Device: levonorgestrel IUS
Levonorgestrel IUS, 52mg placed intrauterine
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.
Drug: Ulipristal acetate
30 mg tablet
Other Name: Ella
- Pregnancy [ Time Frame: 6 weeks ]The primary outcome of this study is unintended pregnancy following emergency contraception
- LARC use at 6 and 12 months [ Time Frame: 12 months ]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: 12 months ]Continuation and satisfaction among participants in the LNG-IUS arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539720
|United States, Georgia|
|Atlanta Women's Center|
|Atlanta, Georgia, United States, 30342|
|United States, Indiana|
|Indiana University School of Medicine|
|Indianapolis, Indiana, United States, 46202|
|United States, Missouri|
|Washington University School of Medicine in St. Louis|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Colleen McNicholas, DO, MCSI||Planned Parenthood of the St. Louis Region and Southwest Missouri|