Trial Outcomes & Findings for Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception (NCT NCT00551616)
NCT ID: NCT00551616
Last Updated: 2022-05-03
Results Overview
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2221 participants
Primary outcome timeframe
Within 72 hours of unprotected Intercourse
Results posted on
2022-05-03
Participant Flow
Participant milestones
| Measure |
CDB-2914
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
Levonorgestrel: Single dose (1.5 mg)
|
|---|---|---|
|
Overall Study
STARTED
|
1104
|
1117
|
|
Overall Study
COMPLETED
|
1056
|
1077
|
|
Overall Study
NOT COMPLETED
|
48
|
40
|
Reasons for withdrawal
| Measure |
CDB-2914
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
Levonorgestrel: Single dose (1.5 mg)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
48
|
40
|
Baseline Characteristics
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
Baseline characteristics by cohort
| Measure |
CDB-2914
n=1104 Participants
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
n=1117 Participants
Levonorgestrel: Single dose (1.5 mg)
|
Total
n=2221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Time from unprotected sexual intercourse to emergency contraception (hours)
97-120h
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Time from unprotected sexual intercourse to emergency contraception (hours)
>120h
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1060 Participants
n=5 Participants
|
1068 Participants
n=7 Participants
|
2128 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
|
24.5 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
24.9 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
24.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1104 Participants
n=5 Participants
|
1117 Participants
n=7 Participants
|
2221 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
|
804 Participants
n=5 Participants
|
809 Participants
n=7 Participants
|
1613 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
210 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Time from unprotected sexual intercourse to emergency contraception (hours)
0-24h
|
367 Participants
n=5 Participants
|
395 Participants
n=7 Participants
|
762 Participants
n=5 Participants
|
|
Time from unprotected sexual intercourse to emergency contraception (hours)
25-48h
|
388 Participants
n=5 Participants
|
378 Participants
n=7 Participants
|
766 Participants
n=5 Participants
|
|
Time from unprotected sexual intercourse to emergency contraception (hours)
49-72h
|
238 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Time from unprotected sexual intercourse to emergency contraception (hours)
73-96h
|
72 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 72 hours of unprotected IntercoursePopulation: Intention to treat
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Outcome measures
| Measure |
CDB-2914
n=1104 Participants
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
n=1117 Participants
Levonorgestrel: Single dose (1.5 mg)
|
|---|---|---|
|
Number of Participants With Pregnancy
|
20 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Within 120 hours of unprotected IntercoursePopulation: Efficacy evaluable population (women aged 35 years or younger who were enrolled for the first time in the study and whose pregnancy status after treatment was known)
Conditional probabilities of pregnancy from the time of unprotected sex intercourse to treatment were estimated for up to 120 hours using Spline Cubic Estimation (Stone \& Koo, 1985) Pregnancy rate expected in the absence of emergency contraception is based on Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception. 1998;57(6):363-9.
Outcome measures
| Measure |
CDB-2914
n=843 Participants
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
n=851 Participants
Levonorgestrel: Single dose (1.5 mg)
|
|---|---|---|
|
Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Number of pregnancies observed
|
15 Participants
|
22 Participants
|
|
Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Number of expected pregnancies
|
47 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: within the menstrual cycle of the unprotected IntercoursePopulation: Intent to Treat
Onset of next menses after emergency contraception compared to usual date.
Outcome measures
| Measure |
CDB-2914
n=1104 Participants
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
n=1117 Participants
Levonorgestrel: Single dose (1.5 mg)
|
|---|---|---|
|
Menstrual Bleeding Patterns
|
2.1 DAYS
Standard Deviation 8.2
|
-1.2 DAYS
Standard Deviation 7.9
|
Adverse Events
CDB-2914
Serious events: 3 serious events
Other events: 596 other events
Deaths: 0 deaths
Levonorgestrel
Serious events: 4 serious events
Other events: 572 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CDB-2914
n=1104 participants at risk
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
n=1117 participants at risk
Levonorgestrel: Single dose (1.5 mg)
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.09%
1/1104 • Number of events 1 • At the most 60 days after treatment.
|
0.00%
0/1117 • At the most 60 days after treatment.
|
|
Eye disorders
Right contact lense related corneal ulcer
|
0.09%
1/1104 • Number of events 1 • At the most 60 days after treatment.
|
0.00%
0/1117 • At the most 60 days after treatment.
|
|
General disorders
Dizziness
|
0.09%
1/1104 • Number of events 1 • At the most 60 days after treatment.
|
0.00%
0/1117 • At the most 60 days after treatment.
|
|
Gastrointestinal disorders
Vomiting blood stained fluid
|
0.00%
0/1104 • At the most 60 days after treatment.
|
0.09%
1/1117 • Number of events 1 • At the most 60 days after treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Molar pregnancy
|
0.00%
0/1104 • At the most 60 days after treatment.
|
0.09%
1/1117 • Number of events 1 • At the most 60 days after treatment.
|
|
Reproductive system and breast disorders
ruptured ovarian cyst
|
0.00%
0/1104 • At the most 60 days after treatment.
|
0.09%
1/1117 • Number of events 1 • At the most 60 days after treatment.
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/1104 • At the most 60 days after treatment.
|
0.09%
1/1117 • Number of events 1 • At the most 60 days after treatment.
|
Other adverse events
| Measure |
CDB-2914
n=1104 participants at risk
CDB-2914: Single dose (30 mg)
|
Levonorgestrel
n=1117 participants at risk
Levonorgestrel: Single dose (1.5 mg)
|
|---|---|---|
|
Nervous system disorders
Headache
|
19.3%
213/1104 • Number of events 213 • At the most 60 days after treatment.
|
18.9%
211/1117 • Number of events 211 • At the most 60 days after treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
12.9%
142/1104 • Number of events 142 • At the most 60 days after treatment.
|
14.3%
160/1117 • Number of events 160 • At the most 60 days after treatment.
|
|
Gastrointestinal disorders
Nausea
|
12.8%
141/1104 • Number of events 141 • At the most 60 days after treatment.
|
11.3%
126/1117 • Number of events 126 • At the most 60 days after treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
56/1104 • Number of events 56 • At the most 60 days after treatment.
|
6.7%
75/1117 • Number of events 75 • At the most 60 days after treatment.
|
|
Nervous system disorders
Dizziness
|
5.1%
56/1104 • Number of events 56 • At the most 60 days after treatment.
|
4.9%
55/1117 • Number of events 55 • At the most 60 days after treatment.
|
|
General disorders
Fatigue
|
5.5%
61/1104 • Number of events 61 • At the most 60 days after treatment.
|
3.9%
44/1117 • Number of events 44 • At the most 60 days after treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place