Drug-drug Interaction of BI 201335 and Microgynon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01570244
First received: April 2, 2012
Last updated: July 3, 2015
Last verified: July 2015
Results First Received: July 3, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: levonorgestrel
Drug: Ethinylestradiol
Drug: BI 201335

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subjects

The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.

Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets.

Period 2: Microgynon tablets and Faldaprevir.


Participant Flow for 2 periods

Period 1:   Microgynon
    All Subjects  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  

Period 2:   Microgynon+Faldaprevir
    All Subjects  
STARTED     16  
COMPLETED     15  
NOT COMPLETED     1  
Adverse Event                 1  



  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.
No text entered.

Reporting Groups
  Description
All Subjects The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean (Standard Deviation)
  28.4  (5.1)  
Gender  
[units: participants]
 
Female     16  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   AUCt,ss of Ethinylestradiol   [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration ]

2.  Primary:   Cmax,ss of Ethinylestradiol   [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]

3.  Primary:   C24,ss of Ethinylestradiol   [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]

4.  Primary:   AUCτ,ss of Levonorgestrel   [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]

5.  Primary:   Cmax,ss of Levonorgestrel   [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]

6.  Primary:   C24,ss of Levonorgestrel   [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]

7.  Secondary:   Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.   [ Time Frame: from drug administration up to 14 days ]

8.  Secondary:   Number of Participants With Drug Related Adverse Events   [ Time Frame: from drug administration up to 14 days ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
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: NCT01570244     History of Changes
Other Study ID Numbers: 1220.56, 2011-006061-17
Study First Received: April 2, 2012
Results First Received: July 3, 2015
Last Updated: July 3, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration