Levonorgestrel Intrauterine System For Emergency Contraception

NCT ID: NCT01539720

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-11-30

Brief 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.

Detailed Description

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 methods of emergency contraception used in the United States are the oral levonorgestrel regimen and oral ulipristal acetate (Ella) regimen which reduce pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine device (Copper IUD). The IUD 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 intrauterine system (LNG-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 LNG-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 emergency contraception, 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 surveys at 6 and 12 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 LNG-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.

Conditions

Pregnancy, Unplanned; Pregnancy; Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

levonorgestrel IUS

Intervention Type: DEVICE

Levonorgestrel IUS, 52mg placed intrauterine

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.

Group Type: ACTIVE_COMPARATOR

Ulipristal acetate

Intervention Type: DRUG

30 mg tablet

Interventions

Ulipristal acetate

30 mg tablet

Intervention Type: DRUG

levonorgestrel IUS

Levonorgestrel IUS, 52mg placed intrauterine

Intervention Type: DEVICE

Other Intervention Names

Ella; Mirena IUD; Liletta

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

William and Flora Hewlett Foundation

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Planned Parenthood Federation of America

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

Planned Parenthood of the St. Louis Region and Southwest Missouri

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colleen McNicholas, DO, MCSI

Role: PRINCIPAL_INVESTIGATOR

Planned Parenthood of the St. Louis Region and Southwest Missouri

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201201007

Identifier Type: -

Identifier Source: org_study_id