Trial Outcomes & Findings for Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception (NCT NCT03614494)
NCT ID: NCT03614494
Last Updated: 2024-05-06
Results Overview
(number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
860 participants
Primary outcome timeframe
1 month
Results posted on
2024-05-06
Participant Flow
A total of 860 women were recruited, all following the recruitment criteria, at the Family Planning Association of Hong Kong, between 20 August 2018 and 30 August 2022.
No per-assignment drop-out.
Participant milestones
| Measure |
Piroxicam
Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
Placebo
Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
|---|---|---|
|
Overall Study
STARTED
|
430
|
430
|
|
Overall Study
COMPLETED
|
418
|
418
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception
Baseline characteristics by cohort
| Measure |
Piroxicam
n=430 Participants
Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
Placebo
n=430 Participants
Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
Total
n=860 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
|
430 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
860 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
|
32.6 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
430 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
860 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
Chinese
|
416 Participants
n=5 Participants
|
417 Participants
n=7 Participants
|
833 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Asians
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
430 participants
n=5 Participants
|
430 participants
n=7 Participants
|
860 participants
n=5 Participants
|
|
Body mass index
|
21.7 kg/m^2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
21.9 kg/m^2
STANDARD_DEVIATION 3.4 • n=7 Participants
|
21.8 kg/m^2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Coitus-treatment interval
|
23.6 hours
STANDARD_DEVIATION 15.2 • n=5 Participants
|
24.4 hours
STANDARD_DEVIATION 15.7 • n=7 Participants
|
24.0 hours
STANDARD_DEVIATION 15.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: efficacy-evaluable participants
(number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265).
Outcome measures
| Measure |
Piroxicam
n=418 Participants
Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
Placebo
n=418 Participants
Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
|---|---|---|
|
Percentage of Pregnancies Prevented
|
94.7 percentage of pregnancies prevented
|
63.3 percentage of pregnancies prevented
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Participants who completed follow-up
number of participants who were pregnant / number of efficacy-evaluable participants
Outcome measures
| Measure |
Piroxicam
n=418 Participants
Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
Placebo
n=418 Participants
Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
|---|---|---|
|
Pregnancy Rate
|
1 Participants
|
7 Participants
|
Adverse Events
Piroxicam
Serious events: 0 serious events
Other events: 117 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Piroxicam
n=418 participants at risk；n=430 participants at risk
Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
Placebo
n=418 participants at risk；n=430 participants at risk
Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose
430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
32/418 • 3 days
|
8.1%
34/418 • 3 days
|
|
General disorders
Fatigue / weakness
|
10.3%
43/418 • 3 days
|
12.4%
52/418 • 3 days
|
|
Nervous system disorders
Dizziness
|
6.2%
26/418 • 3 days
|
6.2%
26/418 • 3 days
|
|
Nervous system disorders
Headache
|
5.0%
21/418 • 3 days
|
6.5%
27/418 • 3 days
|
|
Reproductive system and breast disorders
Breast tenderness
|
6.0%
25/418 • 3 days
|
5.5%
23/418 • 3 days
|
|
Gastrointestinal disorders
Lower abdominal pain
|
7.4%
31/418 • 3 days
|
6.9%
29/418 • 3 days
|
|
Gastrointestinal disorders
Stomachache
|
2.9%
12/418 • 3 days
|
3.3%
14/418 • 3 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place