Trial Outcomes & Findings for EC PK in Women With Normal and Obese BMI (NCT NCT02689804)
NCT ID: NCT02689804
Last Updated: 2017-07-07
Results Overview
LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
Up to 24 hours
Results posted on
2017-07-07
Participant Flow
No significant events in the study that occur after participant enrollment, but prior to assignment of participants to an arm or group.
Participant milestones
| Measure |
Normal-BMI
Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
|
Obese-MRI
Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Normal-BMI
Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
|
Obese-MRI
Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
EC PK in Women With Normal and Obese BMI
Baseline characteristics by cohort
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.8 years
n=99 Participants
|
32.3 years
n=107 Participants
|
30 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hoursPopulation: Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.
LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration
|
208.5 ng*h/mL
Interval 171.4 to 245.6
|
100.8 ng*h/mL
Interval 82.9 to 118.7
|
PRIMARY outcome
Timeframe: Up to 24 hoursPopulation: Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.
UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
|
293.5 ng*h/mL
Interval 237.3 to 349.8
|
362.5 ng*h/mL
Interval 230.9 to 494.1
|
SECONDARY outcome
Timeframe: Up to 24 hoursPopulation: Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.
(t1/2) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Elimination Half-life of Serum LNG
|
27.0 h
Interval 22.2 to 31.8
|
50.4 h
Interval 44.6 to 56.3
|
SECONDARY outcome
Timeframe: Up to 24 hoursPopulation: Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.
(t1/2) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Elimination Half-life of Serum UPA
|
34.9 h
Interval 24.0 to 45.8
|
65.9 h
Interval 50.8 to 81.0
|
SECONDARY outcome
Timeframe: Up to 24 hours(Cl) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Clearance of Serum LNG
|
4.8 L/h
Interval 3.8 to 5.8
|
9.8 L/h
Interval 8.3 to 11.3
|
SECONDARY outcome
Timeframe: Up to 24 hours(Cl) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Clearance of Serum UPA
|
4.1 L/h
Interval 3.2 to 5.0
|
3.0 L/h
Interval 1.8 to 4.2
|
SECONDARY outcome
Timeframe: Up to 24 hours(Cmax) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Maximum Concentration of Serum LNG
|
18.2 ng/mL
Interval 14.0 to 22.4
|
10.8 ng/mL
Interval 6.8 to 14.8
|
SECONDARY outcome
Timeframe: Up to 24 hours(Cmax) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Maximum Concentration of Serum UPA
|
89.3 ng/mL
Interval 57.4 to 121.2
|
95.6 ng/mL
Interval 65.8 to 125.4
|
SECONDARY outcome
Timeframe: Up to 24 hours(Tmax) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Time to Maximum Concentration of Serum LNG
|
2.0 h
Standard Deviation 2.0
|
3.0 h
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Up to 24 hours(Tmax) calculated in women with normal and obese BMI
Outcome measures
| Measure |
Normal-BMI
n=16 Participants
Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
Obese-BMI
n=16 Participants
Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
|
|---|---|---|
|
Time to Maximum Concentration of Serum UPA
|
1.6 h
Standard Deviation 1.0
|
1.5 h
Standard Deviation 1.0
|
Adverse Events
Normal-BMI on LNG
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Normal-BMI on UPA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Obese-BMI on LNG
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Obese-BMI on UPA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal-BMI on LNG
n=8 participants at risk
Women with normal BMI will receive LNG-EC
|
Normal-BMI on UPA
n=8 participants at risk
Women with obese BMI will receive UPA-EC
|
Obese-BMI on LNG
n=8 participants at risk
Women with obese BMI will receive LNG-EC
|
Obese-BMI on UPA
n=8 participants at risk
Women with obese BMI will receive UPA-EC
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
25.0%
2/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
12.5%
1/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
12.5%
1/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
12.5%
1/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
0.00%
0/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
25.0%
2/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
0.00%
0/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
|
Gastrointestinal disorders
Lower abdominal pain
|
0.00%
0/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
25.0%
2/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
0.00%
0/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
0.00%
0/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
|
General disorders
Pain
|
12.5%
1/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
0.00%
0/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
12.5%
1/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
12.5%
1/8 • 8 weeks
The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place