Phase 1
N=18
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01328184 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) — 907; 932 pg*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- levonorgestrel (Drug); Ethinylestradiol (Drug); Microgynon + BI 10773 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) |
907; 932 | — |
| PRIMARY Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) |
94.0; 95.9 | — |
| PRIMARY Ethinylestradiol: Maximum Measured Concentration (Cmax,ss) |
97.6; 96.8 | — |
| PRIMARY Levonorgestrel: Maximum Measured Concentration (Cmax,ss) |
7.98; 8.44 | — |
| SECONDARY Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) |
1.26; 1.50 | — |
| SECONDARY Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) |
1.00; 1.00 | — |
| SECONDARY Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) |
552; 536 | — |
| SECONDARY Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) |
26.6; 26.1 | — |
| SECONDARY Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) |
729; 757 | — |
| SECONDARY Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) |
84.6; 85.0 | — |
| SECONDARY Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) |
15.3; 16.3 | — |
| SECONDARY Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) |
36.7; 37.6 | — |
| SECONDARY Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) |
0.0454; 0.0425 | — |
| SECONDARY Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) |
0.0189; 0.0184 | — |
| SECONDARY Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) |
18.6; 19.5 | — |
| SECONDARY Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) |
48.8; 49.6 | — |
| SECONDARY Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests. |
0; 0 | — |
| SECONDARY Assessment of Tolerability |
94.4; 94.4; 5.6; 5.6; 0.0; 0.0 | — |
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®).
Eligibility Criteria
Inclusion criteria
- Healthy female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01328184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.