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: October 31, 2013
Last verified: October 2013

April 2, 2012
October 31, 2013
April 2012
August 2012   (final data collection date for primary outcome measure)
  • pharmacokinetic interaction (AUCt,ss of ethinylestradiol and levonorgestrel [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 of ethinylestradiol and levonorgestrel [maximum measured concentration over the uniform dosing interval under steady state conditions]) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • C24,ss of ethinylestradiol and levonorgestrel (measured concentration of the analyte at the end of dosing interval under steady state conditions) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01570244 on ClinicalTrials.gov Archive Site
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant changes in electrocardiogram results [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant changes from baseline laboratory measurements [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: upt to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically relevant changes in electrocardiogram results [ Time Frame: upt to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically relevant changes from baseline laboratory measurements [ Time Frame: upt to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Drug-drug Interaction of BI 201335 and Microgynon
An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of 240 mg BI 201335 QD on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: levonorgestrel
    multiple doses
  • Drug: Ethinylestradiol
    multiple doses
  • Drug: BI 201335
    multiple doses
  • Experimental: Reference
    multiple doses of Microgynon
    Interventions:
    • Drug: levonorgestrel
    • Drug: Ethinylestradiol
  • Active Comparator: Test
    multiple doses of Microgynon + BI 201335
    Interventions:
    • Drug: levonorgestrel
    • Drug: Ethinylestradiol
    • Drug: BI 201335
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2012
August 2012   (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 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01570244
1220.56, 2011-006061-17
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

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