Levonorgestrel Intrauterine System For Emergency Contraception (LIFE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy Prevention Emergency Contraception |
Drug: oral levonorgestrel Device: levonorgestrel IUS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial |
- Pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The primary outcome of this study is unintended pregnancy following emergency contraception
- LARC use at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]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: 6 months ] [ Designated as safety issue: No ]Continuation and satisfaction among participants in the LNG-IUS arm
| Estimated Enrollment: | 532 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Levonorgestrel Intrauterine System
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up for urine pregnancy test and string check 5-6 weeks following
|
Device: levonorgestrel IUS
Levonorgestrel IUS, 52mg placed intrauterine
Other Name: Mirena IUD
|
|
Active Comparator: Oral Levonorgestrel
Women in this arm will receive the oral levonorgestrel regimen, which is currently the most commonly used method.
|
Drug: oral levonorgestrel
1.5mg levonorgestrel PO once
Other Name: Plan B, Next Choice
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Colleen P McNicholas, DO | 3147471331 | mcnicholasc@wudosis.wustl.edu |
| Contact: Meghan proehl | 3147471331 | proehlm@wudosis.wustl.edu |
| United States, Missouri | |
| Washington University in St Louis | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Meghan Proehl proehlm@wudosis.wustl.edu | |
| Principal Investigator: Colleen P McNicholas, DO | |
More Information
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01539720 History of Changes |
| Other Study ID Numbers: | 201201007 |
| Study First Received: | February 21, 2012 |
| Last Updated: | February 24, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
emergency contraception Plan B Mirena IUD post-coital contraception |
Additional relevant MeSH terms:
|
Emergencies Disease Attributes Pathologic Processes Levonorgestrel Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 19, 2013