Levonorgestrel Intrauterine System For Emergency Contraception
Status: | Completed |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 14 - 45 |
Updated: | 12/5/2018 |
Start Date: | December 2012 |
End Date: | November 30, 2018 |
Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial
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.
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.
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.
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.
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
We found this trial at
3
sites
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
![Indiana University School of Medicine](/wp-content/uploads/logos/indiana-university-school-of-medicine.jpg)
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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