Trial Outcomes & Findings for Safety and Efficacy of CDB-2914 for Emergency Contraception (NCT NCT00411684)
NCT ID: NCT00411684
Last Updated: 2021-09-21
Results Overview
A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points: * 5-7 days after expected date of menses * 1 week later * every two week after
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1623 participants
Primary outcome timeframe
Up to 60 days after enrollment
Results posted on
2021-09-21
Participant Flow
Screening 1623 Screening failures 90 Enrolled 1533
Participant milestones
| Measure |
CDB-2914
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Overall Study
STARTED
|
1533
|
|
Overall Study
COMPLETED
|
1241
|
|
Overall Study
NOT COMPLETED
|
292
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of CDB-2914 for Emergency Contraception
Baseline characteristics by cohort
| Measure |
Exp Arm
n=1533 Participants
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1533 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.4 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1533 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
338 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
328 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
921 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
212 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1533 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 days after enrollmentPopulation: Primary efficacy population
A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points: * 5-7 days after expected date of menses * 1 week later * every two week after
Outcome measures
| Measure |
CDB-2914
n=1241 Participants
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Pregnancy Rate
|
2.1 percentage of participants
Interval 1.4 to 3.1
|
SECONDARY outcome
Timeframe: within the menstrual cycle of the unprotected IntercoursePopulation: Primary efficacy population
Number of prevented pregnancies divided by the number of expected pregnancies
Outcome measures
| Measure |
CDB-2914
n=1241 Participants
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
|
62.3 percentage of participants
Interval 41.9 to 75.6
|
SECONDARY outcome
Timeframe: within the menstrual cycle of the unprotected IntercoursePopulation: ITT Population
Menstrual cycle length post treatment
Outcome measures
| Measure |
CDB-2914
n=1533 Participants
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Impact on Menstrual Bleeding Patterns
|
31.8 Days
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 12-14 days after expected mensesPopulation: ITT Population
Most common related adverse events in ITT population.
Outcome measures
| Measure |
CDB-2914
n=1533 Participants
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Frequencies of Subjects With Treatment Emergent Adverse Events
Headache
|
9.3 percentage of participants
|
|
Frequencies of Subjects With Treatment Emergent Adverse Events
Nausea
|
9.2 percentage of participants
|
|
Frequencies of Subjects With Treatment Emergent Adverse Events
Abdominal pain
|
6.8 percentage of participants
|
|
Frequencies of Subjects With Treatment Emergent Adverse Events
Dysmenorrhea
|
4.1 percentage of participants
|
|
Frequencies of Subjects With Treatment Emergent Adverse Events
Dizziness
|
3.5 percentage of participants
|
|
Frequencies of Subjects With Treatment Emergent Adverse Events
Fatigue
|
3.4 percentage of participants
|
Adverse Events
CDB-2914
Serious events: 1 serious events
Other events: 557 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CDB-2914
n=1533 participants at risk
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Nervous system disorders
Seizure
|
0.07%
1/1533 • Number of events 3
|
Other adverse events
| Measure |
CDB-2914
n=1533 participants at risk
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
|
|---|---|
|
Nervous system disorders
Headache
|
9.3%
143/1533 • Number of events 143
|
|
Gastrointestinal disorders
Nausea
|
9.2%
141/1533 • Number of events 141
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
104/1533 • Number of events 104
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
4.1%
63/1533 • Number of events 63
|
|
Nervous system disorders
Dizziness
|
3.5%
54/1533 • Number of events 54
|
|
General disorders
Fatigue
|
3.4%
52/1533 • Number of events 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place