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Levonorgestrel Intrauterine System For Emergency Contraception

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy Prevention; Emergency Contraception

Intervention: Ulipristal acetate (Drug); levonorgestrel IUS (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Washington University School of Medicine

Overall contact:
Colleen P McNicholas, DO, Phone: 3147471331, Email: mcnicholasc@wudosis.wustl.edu

Summary

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 method of emergency contraception used in the United States is the oral levonorgestrel regimen which reduces pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine device. The intrauterine device 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 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 levonorgestrel 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 levonorgestrel, 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 survey 6 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 levonorgestrel 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.

Clinical Details

Official title: Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Pregnancy

Secondary outcome:

LARC use at 6 months

Continuation and satisfaction among participants in the LNG-IUS arm

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 (EC), or post-coital contraception, offers significant reductions in the chance of pregnancy following an act of unprotected or under-protected vaginal intercourse. Oral emergency contraception is commonly used in the United States is the oral Ulipristal acetate (Ella) regimen which reduces pregnancy risk by 89-95%. More effective, but rarely used, is the Cu T-380 intrauterine device. The intrauterine device 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 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 levonorgestrel IUS as a form of emergency contraception. The purpose of this study is to evaluate the efficacy of the LNG-IUS (levonorgestrel- intrauterine system) as a method of emergency contraception. Participants will be randomized to receive either the most common method, oral levonorgestrel, or the LNG-IUS. Participants will then be called 5-6 weeks following method allocation for results of a self-administered urine pregnancy test. Lastly, participants will be asked to complete telephone surveys 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 levonorgestrel IUS (intrauterine system) 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women age 18-45

- Under-protected intercourse within the last five days (120 hours)

- Willingness to accept either IUS intervention or oral LNG EC

- Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)

- Ability and willingness to be contacted by phone for 6 month follow-up

Exclusion Criteria:

- Positive pregnancy test

- Non-English speaking

- Contraindication to intrauterine contraception or oral LNG EC

- Inability or unwillingness to comply with follow-up

Locations and Contacts

Colleen P McNicholas, DO, Phone: 3147471331, Email: mcnicholasc@wudosis.wustl.edu

Washington University in St Louis, St Louis, Missouri 63110, United States; Recruiting
Michele Curran, Email: curranm@wudosis.wustl.edu
Colleen P McNicholas, DO, Principal Investigator
Jeffrey F Peipert, MD, Principal Investigator
Additional Information

Starting date: December 2012
Last updated: December 10, 2014

Page last updated: August 23, 2015

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