Trial Outcomes & Findings for Ulipristal Emergency Contraception Used Before or After Ovulation (NCT NCT02517463)
NCT ID: NCT02517463
Last Updated: 2018-07-30
Results Overview
Recruitment status
COMPLETED
Target enrollment
700 participants
Primary outcome timeframe
one cycle (i.e. up to about 4 weeks)
Results posted on
2018-07-30
Participant Flow
700 women were recruited at a community family planning clinic of the Family Plannng Association of Hong Kong, Hong Kong, between May 2011 and March 2014
Participant milestones
| Measure |
Pre-ovulatory
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Post-ovulatory
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
369
|
331
|
|
Overall Study
COMPLETED
|
364
|
329
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Pre-ovulatory
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Post-ovulatory
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
Ulipristal Emergency Contraception Used Before or After Ovulation
Baseline characteristics by cohort
| Measure |
Pre-ovulatory
n=364 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Post-ovulatory
n=329 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Total
n=693 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
364 Participants
n=99 Participants
|
329 Participants
n=107 Participants
|
693 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
31 years
n=99 Participants
|
34 years
n=107 Participants
|
32 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
364 Participants
n=99 Participants
|
329 Participants
n=107 Participants
|
693 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
355 Participants
n=99 Participants
|
322 Participants
n=107 Participants
|
677 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
364 participants
n=99 Participants
|
329 participants
n=107 Participants
|
693 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: one cycle (i.e. up to about 4 weeks)Outcome measures
| Measure |
Pre-ovulatory
n=364 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Post-ovulatory
n=329 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
|---|---|---|
|
Percentage of Pregnancies Prevented (PPP)
|
77.5 percentage of pregnancies prevented
|
36.9 percentage of pregnancies prevented
|
SECONDARY outcome
Timeframe: one cycle (i.e. up to about 4 weeks)Number of subjects who got pregnant / Total number of subjects in the group
Outcome measures
| Measure |
Pre-ovulatory
n=364 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Post-ovulatory
n=329 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
|---|---|---|
|
Failure Rate
|
1.4 percentage of participants
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: one cycle (i.e. up to about 4 weeks)Population: Only subjects with follow-up information were included in this part of analysis
shortening or lengthening of the index menstrual cycle compared to the previous menstrual pattern of the subject
Outcome measures
| Measure |
Pre-ovulatory
n=355 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Post-ovulatory
n=322 Participants
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
|---|---|---|
|
Change in the Length of the Index Menstrual Cycle From Baseline
|
3 days
Interval 0.0 to 6.0
|
-1 days
Interval -3.0 to 1.0
|
Adverse Events
Pre-ovulatory
Serious events: 0 serious events
Other events: 117 other events
Deaths: 0 deaths
Post-ovulatory
Serious events: 0 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-ovulatory
n=364 participants at risk
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
Post-ovulatory
n=329 participants at risk
Ulipristal acetate 30 mg single oral dose
Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
|
|---|---|---|
|
General disorders
Minor complaints
|
32.1%
117/364
|
33.7%
111/329
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place