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Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01328184
First received: April 1, 2011
Last updated: May 16, 2014
Last verified: May 2014

April 1, 2011
May 16, 2014
April 2011
July 2011   (final data collection date for primary outcome measure)
  • Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) [ 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. ] [ Designated as safety issue: No ]
    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) [ 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. ] [ Designated as safety issue: No ]
    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) [ 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. ] [ Designated as safety issue: No ]
    Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
  • Levonorgestrel: Maximum Measured Concentration (Cmax,ss) [ 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. ] [ Designated as safety issue: No ]
    Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
  • pharmacokinetic interaction (AUCt,ss [Area under the curve over the dosing interval t under steady state conditions]) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • pharmacokinetic interaction ( Cmax,ss) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01328184 on ClinicalTrials.gov Archive Site
  • Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) [ 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. ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state
  • Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) [ 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. ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state
  • Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) [ 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. ] [ Designated as safety issue: No ]
    Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration
  • Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) [ 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. ] [ Designated as safety issue: No ]
    Apparent clearance of levonorgestrel in the plasma at steady state after oral administration
  • Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) [ 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. ] [ Designated as safety issue: No ]
    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) [ 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. ] [ Designated as safety issue: No ]
    Apparent volume of distribution during the terminal phase at steady state after oral administration
  • Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) [ 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. ] [ Designated as safety issue: No ]
    Terminal half-life of ethinylestradiol in plasma at steady state
  • Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) [ 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. ] [ Designated as safety issue: No ]
    Terminal half-life of levonorgestrel in plasma at steady state
  • Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) [ 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. ] [ Designated as safety issue: No ]
    Terminal rate constant of ethinylestradiol in plasma at steady state
  • Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) [ 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. ] [ Designated as safety issue: No ]
    Terminal rate constant of levonorgestrel in plasma at steady state
  • Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) [ 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. ] [ Designated as safety issue: No ]
    Mean residence time of ethinylestradiol in the body at steady state after oral administration
  • Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) [ 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. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 to day 17 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within Day 24 to Day 31 ] [ Designated as safety issue: No ]
    Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.
Not Provided
Not Provided
Not Provided
 
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
An Open-label, Two-period, Fixed-sequence Trial to Evaluate the Effect of Multiple Doses of BI 10773 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

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®).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: levonorgestrel
    multiple doses
  • Drug: Ethinylestradiol
    multiple doses
  • Drug: Microgynon + BI 10773
    multiple doses BI 10773
  • Experimental: Reference
    multiple doses of Microgynon
    Interventions:
    • Drug: levonorgestrel
    • Drug: Ethinylestradiol
  • Active Comparator: Test
    multiple doses of Microgynon + BI 10773
    Interventions:
    • Drug: levonorgestrel
    • Drug: Ethinylestradiol
    • Drug: Microgynon + BI 10773
Macha S, Mattheus M, Pinnetti S, Woerle HJ, Broedl UC. Effect of empagliflozin on the steady-state pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female volunteers. Clin Drug Investig. 2013 May;33(5):351-7. doi: 10.1007/s40261-013-0068-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Not Provided
July 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

1. Healthy female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Female
18 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01328184
1245.41, 2010-023432-16
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP