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

NCT ID: NCT01328184

Last Updated: 2014-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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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®).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reference

multiple doses of Microgynon

Group Type EXPERIMENTAL

levonorgestrel

Intervention Type DRUG

multiple doses

Ethinylestradiol

Intervention Type DRUG

multiple doses

Test

multiple doses of Microgynon + BI 10773

Group Type ACTIVE_COMPARATOR

levonorgestrel

Intervention Type DRUG

multiple doses

Ethinylestradiol

Intervention Type DRUG

multiple doses

Microgynon + BI 10773

Intervention Type DRUG

multiple doses BI 10773

Interventions

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levonorgestrel

multiple doses

Intervention Type DRUG

levonorgestrel

multiple doses

Intervention Type DRUG

Ethinylestradiol

multiple doses

Intervention Type DRUG

Microgynon + BI 10773

multiple doses BI 10773

Intervention Type DRUG

Ethinylestradiol

multiple doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy female subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.41.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23512637 (View on PubMed)

Other Identifiers

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2010-023432-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.41

Identifier Type: -

Identifier Source: org_study_id

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