Drug-drug Interaction of BI 201335 and Microgynon

NCT ID: NCT01570244

Last Updated: 2015-08-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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Conditions

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Hepatitis C, Chronic

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 201335

Group Type ACTIVE_COMPARATOR

levonorgestrel

Intervention Type DRUG

multiple doses

Ethinylestradiol

Intervention Type DRUG

multiple doses

BI 201335

Intervention Type DRUG

multiple doses

Interventions

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levonorgestrel

multiple doses

Intervention Type DRUG

Ethinylestradiol

multiple doses

Intervention Type DRUG

levonorgestrel

multiple doses

Intervention Type DRUG

BI 201335

multiple doses

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

35 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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1220.56.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

References

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Sabo JP, Lang B, Elgadi M, Huang F. Effect of the hepatitis C virus protease inhibitor faldaprevir on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel in healthy female volunteers. Antimicrob Agents Chemother. 2015 Jan;59(1):514-9. doi: 10.1128/AAC.03589-14. Epub 2014 Nov 10.

Reference Type DERIVED
PMID: 25385099 (View on PubMed)

Other Identifiers

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2011-006061-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1220.56

Identifier Type: -

Identifier Source: org_study_id

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