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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: levonorgestrel; Drug: Ethinylestradiol; Drug: Microgynon + BI 10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328184

1245.41

2010-023432-16 (EudraCT Number)

Details and patient eligibility

About

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®).

Enrollment: 18 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy female subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Reference

Experimental group

Description:

multiple doses of Microgynon

Treatment:

Drug: Ethinylestradiol

Drug: levonorgestrel

Drug: Ethinylestradiol

Drug: levonorgestrel

Test

Active Comparator group

Description:

multiple doses of Microgynon + BI 10773

Treatment:

Drug: Ethinylestradiol

Drug: Microgynon + BI 10773

Drug: levonorgestrel

Drug: Ethinylestradiol

Drug: levonorgestrel