Trial Outcomes & Findings for Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA (NCT NCT02859337)
NCT ID: NCT02859337
Last Updated: 2024-02-06
Results Overview
Follicular rupture (yes/no) beyond 5 days from EC dosing by ultrasound in participants with a BMI \>/=30 kg/m2. The comparison is between menstrual cycles where 30 versus 60 mg of UPA was taken. Follicular rupture is defined as the disappearance of or \>50% reduction in size of the leading follicle. The day of EC dosing is defined as day zero.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
1 menstrual cycle, assessed up to 38 days
Results posted on
2024-02-06
Participant Flow
Participant milestones
| Measure |
UPA-ECx1 Followed by ECx2
Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
|
UPA-ECx2 Followed by ECx1
Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
|
UPA-ECx1 Normal BMI/Weight
Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
12
|
|
Overall Study
COMPLETED
|
19
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
0
|
Reasons for withdrawal
| Measure |
UPA-ECx1 Followed by ECx2
Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
|
UPA-ECx2 Followed by ECx1
Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
|
UPA-ECx1 Normal BMI/Weight
Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
|
|---|---|---|---|
|
Overall Study
Study drug not dosed (no dominant follicle)
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Baseline characteristics by cohort
| Measure |
UPA-ECx1 Followed by ECx2
n=25 Participants
Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
|
UPA-ECx2 Followed by ECx1
n=27 Participants
Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
|
UPA-ECx1 Normal BMI/Weight
n=12 Participants
Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 3.4 • n=99 Participants
|
28.7 years
STANDARD_DEVIATION 3.7 • n=107 Participants
|
30 years
STANDARD_DEVIATION 3.5 • n=206 Participants
|
29.6 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Declined to specify
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
27 participants
n=107 Participants
|
12 participants
n=206 Participants
|
64 participants
n=7 Participants
|
|
BMI
|
37.9 kg/m2
STANDARD_DEVIATION 6.7 • n=99 Participants
|
39.3 kg/m2
STANDARD_DEVIATION 5.4 • n=107 Participants
|
22.6 kg/m2
STANDARD_DEVIATION 1.4 • n=206 Participants
|
35.2 kg/m2
STANDARD_DEVIATION 8.1 • n=7 Participants
|
PRIMARY outcome
Timeframe: 1 menstrual cycle, assessed up to 38 daysPopulation: The total analyzed number is the menstrual cycle of the participant with a BMI \>/=30kg/m2 when dosed with ECx1 or ECx2 who experienced a delay in follicular rupture beyond 5 days after dosing EC.
Follicular rupture (yes/no) beyond 5 days from EC dosing by ultrasound in participants with a BMI \>/=30 kg/m2. The comparison is between menstrual cycles where 30 versus 60 mg of UPA was taken. Follicular rupture is defined as the disappearance of or \>50% reduction in size of the leading follicle. The day of EC dosing is defined as day zero.
Outcome measures
| Measure |
ECx1 BMI>/=30kg/m2
n=49 Participants
Participants with a BMI \>/=30kg/m2 in the cycle dosed with 30 mg UPA
|
ECx2 BMI >/=30
n=46 Participants
Participants with a BMI \>/=30kg/m2 in the cycle dosed with 60 mg UPA
|
ECx1 BMI <25kg/m2
n=12 Participants
Control group. Participants with a BMI \<25kg/m2 in the cycle dosed with 30 mg UPA.
No planned statistical comparison analysis with the BMI \>/=30 kg/m2 groups
|
|---|---|---|---|
|
Number of Participants With Delay in Follicular Rupture Beyond 5 Days
|
46 Participants
|
43 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: This was a voluntary aspect of the protocol so data were only collected on a subset of the sample.
Maximum serum concentration (Cmax) of UPA in participants with BMI \>/=30 kg/m2 with 30 mg UPA, with BMI \>/= 30 kg/m2 with 60 mg UPA, and normal BMI participants with 30mg UPA
Outcome measures
| Measure |
ECx1 BMI>/=30kg/m2
n=18 Participants
Participants with a BMI \>/=30kg/m2 in the cycle dosed with 30 mg UPA
|
ECx2 BMI >/=30
n=17 Participants
Participants with a BMI \>/=30kg/m2 in the cycle dosed with 60 mg UPA
|
ECx1 BMI <25kg/m2
n=12 Participants
Control group. Participants with a BMI \<25kg/m2 in the cycle dosed with 30 mg UPA.
No planned statistical comparison analysis with the BMI \>/=30 kg/m2 groups
|
|---|---|---|---|
|
Maximum Serum Concentration of Ulipristal Acetate
|
197.1 ng/mL
Standard Deviation 118.5
|
312.4 ng/mL
Standard Deviation 215.3
|
98.4 ng/mL
Standard Deviation 40.7
|
Adverse Events
ECx1 BMI>/=30kg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ECx2 BMI >/=30kg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ECx1 BMI <25kg/m2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place