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: September 26, 2012
Last verified: September 2012

April 1, 2011
September 26, 2012
April 2011
July 2011   (final data collection date for primary outcome measure)
  • pharmacokinetic interaction ( Cmax,ss) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01328184 on ClinicalTrials.gov Archive Site
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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
September 2012

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