RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
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|ClinicalTrials.gov Identifier: NCT02175030|
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Copper IUD Drug: Levonorgestrel IUD||Phase 4|
Unintended pregnancy has multiple adverse effects on both maternal and child health. The United States continues to have one of the highest rates of unintended pregnancy among developed countries. To combat this problem, we are studying initiation of the highly effective intrauterine device (IUD) for women presenting for emergency contraception (EC). This is an ideal population to initiate highly effective reversible contraception (HERC) as they are at high risk of unintended pregnancy and are acting to reduce that risk. We have recently demonstrated significantly lower pregnancy rates 12 months after presenting for EC among women who selected the copper IUD versus those who selected oral Levonorgestrel (LNG).
Not only is the copper IUD the most effective method of EC, it is considered a top tier anticipatory contraception method and its ability to prevent pregnancy is on par with tubal sterilization (less than 1% in the first year with lower failure rates in subsequent years). However, women selecting intrauterine contraception have shown a strong preference for the LNG IUD. The LNG IUD, is as effective at preventing pregnancy as the Copper IUD, and has some non-contraceptive effects that many women see as benefits such as the reduction or elimination of menstrual bleeding and menstrual related discomfort. Of currently available reversible contraceptives, the LNG IUD has the highest levels of user satisfaction and continuation. However, its effectiveness as an emergency contraceptive remains unknown. A randomized control trial is necessary to assess the safety and efficacy of the LNG IUD as EC. Demonstrating the efficacy, safety, and acceptability of the LNG IUD for EC will improve options for women seeking EC and who desire a highly effective method of contraception.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||706 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Copper T380 IUD
Randomized to copper T380 IUD for EC (emergency contraception)
Drug: Copper IUD
Randomization to copper/Paragard IUD for emergency contraception
Other Name: Paragard IUD
Active Comparator: LNG20 IUD
Randomized to LNG20 IUD for EC (emergency contraception)
Drug: Levonorgestrel IUD
Randomization to Levonorgestrel/Mirena IUD for emergency contraception
Other Name: Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD
- Determine the efficacy of the levonorgestrel IUD and copper T380 IUD for emergency contraception as assessed by urine pregnancy tests 1 month after EC use. [ Time Frame: 1 month after enrollment ]Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic.
- Compare the one-year unintended pregnancy rates from women initiating the levonorgestrel IUD vs. copper T380 IUD for EC. [ Time Frame: 1 year after enrollment ]Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175030
|Contact: Marie Gibsonemail@example.com|
|Contact: Jessica Sanders, PhDfirstname.lastname@example.org|
|United States, Utah|
|Planned Parenthood Association of Utah||Recruiting|
|West Valley City, Utah, United States, 84119|
|Contact: Marie Gibson 801-213-2845 email@example.com|
|Contact: Jessica Sanders, PhD 801-581-6170 firstname.lastname@example.org|
|Principal Investigator: David K Turok, MD|
|Principal Investigator:||David Turok, MD||University of Utah|