Levonorgestrel Intrauterine System For Emergency Contraception

• Status: Completed
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri; Washington University School of Medicine
• Collaborators: Planned Parenthood Federation of America; University of Colorado, Denver; University of Rochester; William and Flora Hewlett Foundation
• Treatments: Levonorgestrel; Ulipristal acetate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Positive pregnancy test

• Non-English speaking

• Contraindication to intrauterine contraception or oral EC

• Inability or unwillingness to comply with follow-up