Healthy
Conditions
Brief summary
The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).
Interventions
DRUGlevonorgestrel
multiple doses
DRUGEthinylestradiol
multiple doses
DRUGMicrogynon + BI 10773
multiple doses BI 10773
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Healthy female subjects
Exclusion criteria
1\. Any relevant deviation from healthy conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ. |
| Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ. |
| Ethinylestradiol: Maximum Measured Concentration (Cmax,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ. |
| Levonorgestrel: Maximum Measured Concentration (Cmax,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Apparent volume of distribution during the terminal phase at steady state after oral administration |
| Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Apparent volume of distribution during the terminal phase at steady state after oral administration |
| Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Terminal half-life of ethinylestradiol in plasma at steady state |
| Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Terminal half-life of levonorgestrel in plasma at steady state |
| Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Terminal rate constant of ethinylestradiol in plasma at steady state |
| Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state |
| Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Mean residence time of ethinylestradiol in the body at steady state after oral administration |
| Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Mean residence time of levonorgestrel in the body at steady state after oral administration |
| Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests. | Day 1 to day 17 | Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events. |
| Assessment of Tolerability | Within Day 24 to Day 31 | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable. |
| Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Terminal rate constant of levonorgestrel in plasma at steady state |
| Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state |
| Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration |
| Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. | Apparent clearance of levonorgestrel in the plasma at steady state after oral administration |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Overall A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Study Overall |
|---|---|
| Age, Continuous | 27.2 years STANDARD_DEVIATION 4.1 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 18 | 10 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | 907 pg*h/mL | Geometric Coefficient of Variation 24.4 |
| Microgynon Plus Empa | Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | 932 pg*h/mL | Geometric Coefficient of Variation 22.8 |
Comparison: No formal testing, investigation of relative bioavailability.90% CI: [97.58, 108.35]ANOVA
Primary
Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)
Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Maximum Measured Concentration (Cmax,ss) | 97.6 pg/mL | Geometric Coefficient of Variation 17.6 |
| Microgynon Plus Empa | Ethinylestradiol: Maximum Measured Concentration (Cmax,ss) | 96.8 pg/mL | Geometric Coefficient of Variation 21.8 |
Comparison: No formal testing, investigation of relative bioavailability.90% CI: [93.4, 105.39]ANOVA
Primary
Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | 94.0 ng*h/mL | Geometric Coefficient of Variation 34.4 |
| Microgynon Plus Empa | Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | 95.9 ng*h/mL | Geometric Coefficient of Variation 36.6 |
Comparison: No formal testing, investigation of relative bioavailability.90% CI: [98.54, 105.47]ANOVA
Primary
Levonorgestrel: Maximum Measured Concentration (Cmax,ss)
Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Maximum Measured Concentration (Cmax,ss) | 7.98 ng/mL | Geometric Coefficient of Variation 26.1 |
| Microgynon Plus Empa | Levonorgestrel: Maximum Measured Concentration (Cmax,ss) | 8.44 ng/mL | Geometric Coefficient of Variation 25.8 |
Comparison: No formal testing, investigation of relative bioavailability.90% CI: [99.47, 112.55]ANOVA
Secondary
Assessment of Tolerability
Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.
Time frame: Within Day 24 to Day 31
Population: Treated set (TS) included all subjects who took at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Microgynon | Assessment of Tolerability | Satisfactory | 5.6 percentage of participants |
| Microgynon | Assessment of Tolerability | Bad | 0.0 percentage of participants |
| Microgynon | Assessment of Tolerability | Not satisfactory | 0.0 percentage of participants |
| Microgynon | Assessment of Tolerability | Not assessable | 0.0 percentage of participants |
| Microgynon | Assessment of Tolerability | Good | 94.4 percentage of participants |
| Microgynon Plus Empa | Assessment of Tolerability | Not assessable | 0.0 percentage of participants |
| Microgynon Plus Empa | Assessment of Tolerability | Good | 94.4 percentage of participants |
| Microgynon Plus Empa | Assessment of Tolerability | Satisfactory | 5.6 percentage of participants |
| Microgynon Plus Empa | Assessment of Tolerability | Not satisfactory | 0.0 percentage of participants |
| Microgynon Plus Empa | Assessment of Tolerability | Bad | 0.0 percentage of participants |
Secondary
Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)
Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) | 552 mL/min | Geometric Coefficient of Variation 24.4 |
| Microgynon Plus Empa | Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) | 536 mL/min | Geometric Coefficient of Variation 22.8 |
Secondary
Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
Apparent volume of distribution during the terminal phase at steady state after oral administration
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | 729 L | Geometric Coefficient of Variation 35.1 |
| Microgynon Plus Empa | Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | 757 L | Geometric Coefficient of Variation 30.3 |
Secondary
Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)
Mean residence time of ethinylestradiol in the body at steady state after oral administration
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) | 18.6 hours(h) | Geometric Coefficient of Variation 28.1 |
| Microgynon Plus Empa | Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) | 19.5 hours(h) | Geometric Coefficient of Variation 20.5 |
Secondary
Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)
Terminal half-life of ethinylestradiol in plasma at steady state
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) | 15.3 hours(h) | Geometric Coefficient of Variation 28.8 |
| Microgynon Plus Empa | Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) | 16.3 hours(h) | Geometric Coefficient of Variation 21.8 |
Secondary
Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)
Terminal rate constant of ethinylestradiol in plasma at steady state
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) | 0.0454 1/h | Geometric Coefficient of Variation 28.8 |
| Microgynon Plus Empa | Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) | 0.0425 1/h | Geometric Coefficient of Variation 21.8 |
Secondary
Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Microgynon | Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | 1.26 hours(h) | Full Range 39.5 |
| Microgynon Plus Empa | Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | 1.50 hours(h) | Full Range 34.2 |
Secondary
Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)
Apparent clearance of levonorgestrel in the plasma at steady state after oral administration
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) | 26.6 mL/min | Geometric Coefficient of Variation 34.4 |
| Microgynon Plus Empa | Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) | 26.1 mL/min | Geometric Coefficient of Variation 36.6 |
Secondary
Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
Apparent volume of distribution during the terminal phase at steady state after oral administration
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | 84.6 L | Geometric Coefficient of Variation 41.1 |
| Microgynon Plus Empa | Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | 85.0 L | Geometric Coefficient of Variation 38.8 |
Secondary
Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)
Mean residence time of levonorgestrel in the body at steady state after oral administration
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) | 48.8 hours(h) | Geometric Coefficient of Variation 33.1 |
| Microgynon Plus Empa | Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) | 49.6 hours(h) | Geometric Coefficient of Variation 41.2 |
Secondary
Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)
Terminal half-life of levonorgestrel in plasma at steady state
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) | 36.7 hours(h) | Geometric Coefficient of Variation 32.4 |
| Microgynon Plus Empa | Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) | 37.6 hours(h) | Geometric Coefficient of Variation 40.7 |
Secondary
Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)
Terminal rate constant of levonorgestrel in plasma at steady state
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) | 0.0189 1/h | Geometric Coefficient of Variation 32.4 |
| Microgynon Plus Empa | Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) | 0.0184 1/h | Geometric Coefficient of Variation 40.7 |
Secondary
Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Population: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Microgynon | Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | 1.00 hours(h) | Full Range 28.1 |
| Microgynon Plus Empa | Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | 1.00 hours(h) | Full Range 25.5 |
Secondary
Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.
Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.
Time frame: Day 1 to day 17
Population: Treated set (TS) included all subjects who took at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Microgynon | Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests. | 0 participants |
| Microgynon Plus Empa | Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests. | 0 participants |