Trial Outcomes & Findings for RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC (NCT NCT02175030)
NCT ID: NCT02175030
Last Updated: 2022-06-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
711 participants
Primary outcome timeframe
1 month after enrollment
Results posted on
2022-06-29
Participant Flow
Participant milestones
| Measure |
Copper T380 IUD
Randomized to copper T380 IUD for EC (emergency contraception)
Copper IUD: Randomization to copper/Paragard IUD for emergency contraception
|
LNG20 IUD
Randomized to LNG20 IUD for EC (emergency contraception)
Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception
|
|---|---|---|
|
Overall Study
STARTED
|
356
|
355
|
|
Overall Study
COMPLETED
|
321
|
317
|
|
Overall Study
NOT COMPLETED
|
35
|
38
|
Reasons for withdrawal
| Measure |
Copper T380 IUD
Randomized to copper T380 IUD for EC (emergency contraception)
Copper IUD: Randomization to copper/Paragard IUD for emergency contraception
|
LNG20 IUD
Randomized to LNG20 IUD for EC (emergency contraception)
Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception
|
|---|---|---|
|
Overall Study
Failed screen after consent
|
7
|
6
|
|
Overall Study
Failed IUD Insertion
|
20
|
21
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
Baseline Characteristics
RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
Baseline characteristics by cohort
| Measure |
Copper T380 IUD
n=328 Participants
Randomized to copper T380 IUD for EC (emergency contraception)
Copper IUD: Randomization to copper/Paragard IUD for emergency contraception
|
LNG20 IUD
n=327 Participants
Randomized to LNG20 IUD for EC (emergency contraception)
Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception
|
Total
n=655 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
328 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
655 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.9 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
24.0 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
328 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
655 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
182 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latina
|
101 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian / Pacific Islander
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
328 participants
n=5 Participants
|
327 participants
n=7 Participants
|
655 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after enrollmentPopulation: Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic.
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.
Outcome measures
| Measure |
Copper T380 IUD
n=321 Participants
Randomized to copper T380 IUD for EC (emergency contraception)
Copper IUD: Randomization to copper/Paragard IUD for emergency contraception
|
LNG20 IUD
n=317 Participants
Randomized to LNG20 IUD for EC (emergency contraception)
Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception
|
|---|---|---|
|
Percentage of Participants Reporting a Pregnancy
|
0 % of participants reporting pregnancy
Interval 0.0 to 1.1
|
0.3 % of participants reporting pregnancy
Interval 0.01 to 1.7
|
SECONDARY outcome
Timeframe: 1 year after enrollmentPopulation: 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.
Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded.
Outcome measures
| Measure |
Copper T380 IUD
n=313 Participants
Randomized to copper T380 IUD for EC (emergency contraception)
Copper IUD: Randomization to copper/Paragard IUD for emergency contraception
|
LNG20 IUD
n=315 Participants
Randomized to LNG20 IUD for EC (emergency contraception)
Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception
|
|---|---|---|
|
Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.
|
7 Participants
|
7 Participants
|
Adverse Events
Copper T380 IUD
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
LNG20 IUD
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Copper T380 IUD
n=328 participants at risk
Randomized to copper T380 IUD for EC (emergency contraception)
Copper IUD: Randomization to copper/Paragard IUD for emergency contraception
|
LNG20 IUD
n=327 participants at risk
Randomized to LNG20 IUD for EC (emergency contraception)
Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception
|
|---|---|---|
|
Reproductive system and breast disorders
Adverse events experienced related to IUD at 1-Month
|
4.9%
16/328 • Number of events 16 • Adverse event data was collected during the year of follow-up collectively and defined as all events requiring additional medical care in the first month of use of IUD.
Definition of adverse events does not differ from definition used by clinical trials.gov. Adverse events were collected as part of routine follow-up surveys completed by participants and reviewed by PI for determination of Serious Adverse Event collectively and reported collectively as all events requiring additional medical care in the first month of use after IUD insertion.
|
5.2%
17/327 • Number of events 17 • Adverse event data was collected during the year of follow-up collectively and defined as all events requiring additional medical care in the first month of use of IUD.
Definition of adverse events does not differ from definition used by clinical trials.gov. Adverse events were collected as part of routine follow-up surveys completed by participants and reviewed by PI for determination of Serious Adverse Event collectively and reported collectively as all events requiring additional medical care in the first month of use after IUD insertion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place