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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01328184

First received: April 1, 2011

Last updated: September 26, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2011

Last Updated Date

September 26, 2012

Start Date ^ICMJE

April 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01328184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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®).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: levonorgestrel
multiple doses
Drug: Ethinylestradiol
multiple doses
Drug: Microgynon + BI 10773
multiple doses BI 10773

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

1. Healthy female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Gender

Female

Ages

18 Years to 39 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01328184

Other Study ID Numbers ^ICMJE

1245.41, 2010-023432-16

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

September 2012

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

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