Levonorgestrel Intrauterine System For Emergency Contraception

Completed · Not applicable

Conditions studied: Pregnancy, Unplanned, Pregnancy; Accident

In brief

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.

Key facts

Study ID

NCT01539720

Run by

Planned Parenthood of the St. Louis Region and Southwest Missouri

People needed

274

Starts

2012-12-01

Expected to finish

2018-11-30

Last updated by the study team

2024-02-20

Who can join

Age: 14 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women age 14-45
• Under-protected intercourse within the last five days (120 hours)
• Willingness to accept either intervention: intrauterine contraception or oral emergency contraception (EC)
• Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)
• Ability and willingness to be contacted by phone for 6 and 12 month follow-up

You may not qualify if…

• Positive pregnancy test
• Non-English speaking
• Contraindication to intrauterine contraception or oral EC
• Inability or unwillingness to comply with follow-up

Where it is running

• Atlanta Women's Center — Atlanta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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