Contraception
Conditions
Keywords
Emergency contraception, Levonorgestrel IUD, Copper IUD
Brief summary
This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. This research has the potential to increase use of highly effective contraception in a high-risk population and lower the persistently elevated rate of U.S. unintended pregnancy.
Detailed description
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.
Interventions
DRUGCopper IUD
Randomization to copper/Paragard IUD for emergency contraception
Randomization to Levonorgestrel/Mirena IUD for emergency contraception
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Females between 18-35 years old * In need of EC (had unprotected intercourse within 120 hours - 5 days) * Desire to prevent pregnancy for 1 year * Fluent in English and/or Spanish * Have a regular menstrual cycle (21-35 days) * Know their last menstrual period (+/-3 days) * Be willing to comply with the study requirements * Desire to initiate an IUD * Negative urine pregnancy test
Exclusion criteria
* Current pregnancy * Breastfeeding * Intrauterine infection within the past three months * Sterilization * Already have an IUD or contraception implant (Nexplanon) in place * Vaginal bleeding of unknown etiology * Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry) * Known abnormalities of the uterus that distort the uterine cavity * Allergy to copper * Use of oral Emergency Contraception in the preceeding 5 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting a Pregnancy | 1 month after enrollment | Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic. We will use the total number of pregnancies per ARM and the overall number of participants analyzed per ARM to calculate, for each ARM, the percentage of participants reporting a pregnancy in the first month of use of the IUD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year. | 1 year after enrollment | Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Copper T380 IUD Randomized to copper T380 IUD for EC (emergency contraception)
Copper IUD: Randomization to copper/Paragard IUD for emergency contraception | 328 |
| LNG20 IUD Randomized to LNG20 IUD for EC (emergency contraception)
Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception | 327 |
| Total | 655 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed IUD Insertion | 20 | 21 |
| Overall Study | Failed screen after consent | 7 | 6 |
| Overall Study | Lost to Follow-up | 6 | 6 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | LNG20 IUD | Copper T380 IUD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 327 Participants | 328 Participants | 655 Participants |
| Age, Continuous | 24.0 years STANDARD_DEVIATION 4.9 | 23.9 years STANDARD_DEVIATION 4.6 | 24.0 years STANDARD_DEVIATION 4.7 |
| Race/Ethnicity, Customized American Indian / Alaska Native | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Black / African American | 12 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized Hispanic / Latina | 111 Participants | 101 Participants | 212 Participants |
| Race/Ethnicity, Customized More than one race | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Native Hawaiian / Pacific Islander | 5 Participants | 8 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 171 Participants | 182 Participants | 353 Participants |
| Region of Enrollment United States | 327 participants | 328 participants | 655 participants |
| Sex: Female, Male Female | 327 Participants | 328 Participants | 655 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 328 | 0 / 327 |
| other Total, other adverse events | 16 / 328 | 17 / 327 |
| serious Total, serious adverse events | 0 / 328 | 0 / 327 |
Outcome results
Primary
Percentage of Participants Reporting a Pregnancy
Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic. We will use the total number of pregnancies per ARM and the overall number of participants analyzed per ARM to calculate, for each ARM, the percentage of participants reporting a pregnancy in the first month of use of the IUD.
Time frame: 1 month after enrollment
Population: Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Copper T380 IUD | Percentage of Participants Reporting a Pregnancy | 0 % of participants reporting pregnancy |
| LNG20 IUD | Percentage of Participants Reporting a Pregnancy | 0.3 % of participants reporting pregnancy |
Secondary
Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.
Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded.
Time frame: 1 year after enrollment
Population: This denominator excludes participants lost to follow-up and participants who cited a desire for pregnancy as their reason for removing their IUD, but includes all other participants who removed their IUD throughout the 12 months follow-up and all participants with an expelled IUD.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Copper T380 IUD | Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year. | 7 Participants |
| LNG20 IUD | Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year. | 7 Participants |