Trial Outcomes & Findings for Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions. (NCT NCT01182194)
NCT ID: NCT01182194
Last Updated: 2010-12-08
Results Overview
Bioequivalence based on Drospirenone AUC0-inf.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Blood samples collected over a 120 hour period.
Results posted on
2010-12-08
Participant Flow
Participant milestones
| Measure |
Drospirenone/Ethinyl Estradiol (Test) First
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
|
YAZ® (Reference) First
3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
16
|
|
First Intervention
COMPLETED
|
16
|
16
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 28 Days
STARTED
|
16
|
16
|
|
Washout of 28 Days
COMPLETED
|
15
|
16
|
|
Washout of 28 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
15
|
16
|
|
Second Intervention
COMPLETED
|
15
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Drospirenone/Ethinyl Estradiol (Test) First
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
|
YAZ® (Reference) First
3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
|
|---|---|---|
|
Washout of 28 Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.
Baseline characteristics by cohort
| Measure |
Drospirenone/Ethinyl Estradiol (Test) First
n=16 Participants
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
|
YAZ® (Reference) First
n=16 Participants
3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
More than One
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
32 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 120 hour period.Population: Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.
Bioequivalence based on Drospirenone Cmax.
Outcome measures
| Measure |
Drospirenone/Ethinyl Estradiol (Test)
n=30 Participants
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
|
YAZ® (Reference)
n=30 Participants
3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)
|
67.69 ng/mL
Standard Deviation 12.49
|
74.33 ng/mL
Standard Deviation 15.35
|
PRIMARY outcome
Timeframe: Blood samples collected over a 120 hour period.Population: Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.
Bioequivalence based on Drospirenone AUC0-t.
Outcome measures
| Measure |
Drospirenone/Ethinyl Estradiol (Test)
n=30 Participants
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
|
YAZ® (Reference)
n=30 Participants
3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
814.32 ng*h/mL
Standard Deviation 200.60
|
824.41 ng*h/mL
Standard Deviation 194.63
|
PRIMARY outcome
Timeframe: Blood samples collected over a 120 hour period.Population: Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.
Bioequivalence based on Drospirenone AUC0-inf.
Outcome measures
| Measure |
Drospirenone/Ethinyl Estradiol (Test)
n=30 Participants
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
|
YAZ® (Reference)
n=30 Participants
3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)
|
866.91 ng*h/mL
Standard Deviation 228.41
|
884.24 ng*h/mL
Standard Deviation 248.36
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.
Bioequivalence based on Ethinyl Estradiol Cmax.
Outcome measures
| Measure |
Drospirenone/Ethinyl Estradiol (Test)
n=29 Participants
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
|
YAZ® (Reference)
n=29 Participants
3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
|
128.87 pg/mL
Standard Deviation 39.70
|
126.03 pg/mL
Standard Deviation 35.74
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.
Bioequivalence based on Ethinyl Estradiol AUC0-t.
Outcome measures
| Measure |
Drospirenone/Ethinyl Estradiol (Test)
n=29 Participants
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
|
YAZ® (Reference)
n=29 Participants
3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
1145.90 pg*h/mL
Standard Deviation 322.08
|
1155.31 pg*h/mL
Standard Deviation 309.12
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.
Bioequivalence based on Ethinyl Estradiol AUC0-inf.
Outcome measures
| Measure |
Drospirenone/Ethinyl Estradiol (Test)
n=29 Participants
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
|
YAZ® (Reference)
n=29 Participants
3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
|
1236.96 pg*h/mL
Standard Deviation 331.63
|
1235.91 pg*h/mL
Standard Deviation 324.28
|
Adverse Events
Drospirenone/Ethinyl Estradiol (Test) First
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
YAZ® (Reference) First
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Drospirenone/Ethinyl Estradiol (Test) First
n=32 participants at risk
3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
|
YAZ® (Reference) First
n=32 participants at risk
3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
|
|---|---|---|
|
General disorders
Menstruation Irregular
|
6.2%
2/32 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Headache
|
21.9%
7/32 • Number of events 10 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
12.5%
4/32 • Number of events 7 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Dysmenorrhoea
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
6.2%
2/32 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Nausea
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
12.5%
4/32 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
Additional Information
Associate Director, Biopharmaceutics
TEVA Pharmaceuticals, USA
Phone: 1-866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER