Trial Outcomes & Findings for Levonorgestrel Intrauterine System For Emergency Contraception (NCT NCT01539720)
NCT ID: NCT01539720
Last Updated: 2024-02-20
Results Overview
Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
274 participants
Primary outcome timeframe
5 weeks post-randomization
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Levonorgestrel Intrauterine System
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.
levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine
|
Ulipristal Acetate
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.
Ulipristal acetate: 30 mg tablet
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
76
|
|
Overall Study
5 WEEKS
|
183
|
73
|
|
Overall Study
6 MONTHS
|
169
|
66
|
|
Overall Study
COMPLETED
|
169
|
66
|
|
Overall Study
NOT COMPLETED
|
29
|
10
|
Reasons for withdrawal
| Measure |
Levonorgestrel Intrauterine System
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.
levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine
|
Ulipristal Acetate
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.
Ulipristal acetate: 30 mg tablet
|
|---|---|---|
|
Overall Study
Screen Fail
|
15
|
3
|
|
Overall Study
Lost to Follow-up
|
14
|
7
|
Baseline Characteristics
Levonorgestrel Intrauterine System For Emergency Contraception
Baseline characteristics by cohort
| Measure |
Levonorgestrel Intrauterine System
n=183 Participants
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.
levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine
|
Ulipristal Acetate
n=73 Participants
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.
Ulipristal acetate: 30 mg tablet
|
Total
n=256 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
|
183 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
256 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
|
27.7 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
27.1 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
27.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
66 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
93 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=5 Participants
|
73 participants
n=7 Participants
|
256 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 weeks post-randomizationPopulation: total eligible for analysis after 5-6 weeks post randomization = 256; total eligible for analysis after 6 months post randomization = 235
Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System
n=183 Participants
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.
levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine
|
Ulipristal Acetate
n=73 Participants
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.
Ulipristal acetate: 30 mg tablet
|
|---|---|---|
|
Number of Participants With Pregnancy Following Emergency Contraception
Pregnancy at 5 weeks post randomization.
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pregnancy Following Emergency Contraception
Pregnancy at 6 months post randomization.
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 months post randomizationThe number of participants who reported using any type of long acting reversible contraception (LARC) use at 6 months following method allocation will be evaluated, whether or not it was their allocated LNG-IUS.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System
n=169 Participants
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.
levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine
|
Ulipristal Acetate
n=66 Participants
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.
Ulipristal acetate: 30 mg tablet
|
|---|---|---|
|
Number of Participants Using Any LARC Method at 6 Months Post Randomization
|
95 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: 169 = total eligible for analysis from randomized LNG-IUS arm; at 6 months post randomization, 92 of 169 were still using LNG-IUS, so only 92 eligible to analyze satisfaction with LNG-IUS at 6 months post randomization.
Continuation and satisfaction among participants in the LNG-IUS arm who reported still using their LNG-IUS at 6 month post randomization.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System
n=169 Participants
Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.
levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine
|
Ulipristal Acetate
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.
Ulipristal acetate: 30 mg tablet
|
|---|---|---|
|
Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS
Continuation of LNG-IUS at 6 months
|
92 Participants
|
—
|
|
Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS
Satisfaction with LNG-IUS at 6 months
|
82 Participants
|
—
|
Adverse Events
Levonorgestrel Intrauterine System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ulipristal Acetate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Research
Planned Parenthood of the St. Louis Region and Southwest Missouri
Phone: 314-531-7526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place