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
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: levonorgestrel
Drug: Ethinylestradiol
Drug: Microgynon + BI 10773

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Study Overall  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Baseline Measures
    Study Overall  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ± Standard Deviation
  27.2  ± 4.1  
Gender  
[units: participants]
 
Female     18  
Male     0  



  Outcome Measures
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1.  Primary:   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. ]

2.  Primary:   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. ]

3.  Primary:   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. ]

4.  Primary:   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. ]

5.  Secondary:   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. ]

6.  Secondary:   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. ]

7.  Secondary:   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. ]

8.  Secondary:   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. ]

9.  Secondary:   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. ]

10.  Secondary:   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. ]

11.  Secondary:   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. ]

12.  Secondary:   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. ]

13.  Secondary:   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. ]

14.  Secondary:   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. ]

15.  Secondary:   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. ]

16.  Secondary:   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. ]

17.  Secondary:   Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.   [ Time Frame: Day 1 to day 17 ]

18.  Secondary:   Assessment of Tolerability   [ Time Frame: Within Day 24 to Day 31 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01328184     History of Changes
Other Study ID Numbers: 1245.41, 2010-023432-16
Study First Received: April 1, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration